[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Valenta Pharm JSC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":293},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,43,65,87,109,130,148,172,190,205,225,246,268],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100642084","phase-1-safety-and-pharmacokinetics-of-ingavirin-forte-capsules-90-mg--20-mg-valenta-pharm-jsc-russia-compared-with-ingavirin-capsules-90-mg-under-fasting-and-fed-conditions-100642084",false,"NCT07645534","Safety and Pharmacokinetics of Ingavirin Forte, Capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) Compared With Ingavirin, Capsules, 90 mg, Under Fasting and Fed Conditions.","An Open-Label, Randomized, Crossover Clinical Study to Evaluate the Safety and Pharmacokinetics of the Active Ingredients of Ingavirin Forte, Capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) Fixed-Dose Combination Compared With Single-Ingredient Drug Ingavirin, Capsules, 90 mg Under Fasting and Fed Conditions.","Inclusion Criteria:\n\n1. Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;\n2. Males and females aged 18 to 45 years (inclusive);\n3. Confirmed healthy status, defined as the absence of clinically significant abnormalities based on clinical evaluation, laboratory assessments, and diagnostic procedures as specified in the protocol;\n4. Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 130 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mmHg (inclusive);\n5. Heart rate (HR) from 60 to 89 beats\u002Fmin (inclusive);\n6. Respiratory rate (RR) from 12 to 20 per minute (inclusive);\n7. Body temperature from 36.0°C to 36.9°C (inclusive);\n8. Body mass index (BMI) of 18.5 kg\u002Fm² ≤ BMI ≤ 30 kg\u002Fm², with body weight for men being ≥ 55 kg and for women ≥ 45 kg;\n9. Agreement to use adequate methods of contraception throughout the study and for 30 days after its completion; for women of childbearing potential - a negative urine β-hCG test result;\n10. Subjects must demonstrate appropriate behavior and coherent speech;\n11. Ability to comply with the daily routine and diet prescribed by the study protocol.\n\nNoninclusion Criteria:\n\n1. Clinically significant allergic history;\n2. History of hypersensitivity to imidazolylethanamide of pentanedioic acid and N,N'-bis-\\[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl\\] diamide of malonic acid (XC9) and\u002For to the excipients contained in the investigational medicinal product;\n3. History of drug intolerance to imidazolylethanamide of pentanedioic acid and N,N'-bis-\\[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl\\] diamide of malonic acid (XC9) and\u002For to the excipients contained in the investigational medicinal product;\n4. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;\n5. Chronic diseases of the kidneys, liver, gastrointestinal (GI) tract, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary, or immune systems, or of the skin, hematopoietic organs, or eyes;\n6. History of gastrointestinal (GI) surgical procedures, with the exception of appendectomy performed at least 1 year prior to screening;\n7. Diseases\u002Fconditions that, in the investigator's opinion, may affect the absorption, distribution, metabolism, or excretion of the investigational medicinal product (IMP);\n8. Acute infectious diseases less than 4 weeks prior to screening;\n9. Use of medicinal products (MPs) that have a pronounced effect on hemodynamics, MPs affecting liver function (barbiturates, omeprazole, cimetidine, etc.), MPs prolonging the QT interval (antipsychotics (haloperidol, quetiapine, olanzapine, risperidone, sulpiride), antidepressants (fluoxetine, sertraline), antiarrhythmics (amiodarone), antibiotics (clarithromycin, azithromycin, moxifloxacin, levofloxacin, ciprofloxacin), antifungals (fluconazole), diuretics (furosemide)) less than 2 months prior to screening;\n10. Regular use of MPs less than 2 weeks prior to screening and single use of MPs less than 7 days prior to screening (including over-the-counter MPs, vitamins, dietary supplements, herbal medicinal products);\n11. Donation of blood or plasma less than 3 months prior to screening;\n12. Use of hormonal contraceptives by womeninitiated less than 2 months prior to the screening visit.\n13. Use of depot injections of any MPs less than 3 months prior to the start of screening;\n14. Pregnancy or breastfeeding; positive urine pregnancy test result for women of childbearing potential;\n15. Women of childbearing potential with a history of unprotected sexual intercourse within 30 days prior to study drug administration with a non-sterilized partner;\n16. Participation in another clinical trial within 3 months prior to screening or concurrently with the current study.\n17. Consumption of more than 10 standard alcohol units per week during the month prior to study enrollment, (1 standard unit = 500 mL beer, 200 mL wine, or 50 mL of strong alcoholic beverages), or history of alcoholism, drug dependence, or substance abuse.\n18. Currently smoking more than 10 cigarettes per day, or a history of smoking the specified number of cigarettes within the 6 months preceding screening; refusal to abstain from smoking while staying at the study center;\n19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to IMP administration;\n20. Consumption of citrus fruits, cranberries, rose hips and products containing them, or St. John's wort-containing preparations or products within 7 days prior to IMP administration;\n21. Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours prior to IMP administration;\n22. Positive blood test result for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), or antibodies to hepatitis C virus antigens at screening;\n23. Clinically significant abnormalities on the electrocardiogram (ECG) in the medical history and\u002For at screening, including: QTcF interval (corrected by Fredericia) ≥430 ms in men and ≥450 ms in women;\n24. History of risk factors for torsades de pointes, such as heart failure, hypokalemia, or family history of long QT syndrome;\n25. Electrolyte imbalances (based on Na+, K+, Cl- levels at screening);\n26. Positive urine test for narcotic substances and potent medicinal products at screening;\n27. Positive breath alcohol test at screening;\n28. Planned hospitalization during the study period for any reason other than hospitalization required by this protocol;\n29. Inability or incapacity to comply with the protocol requirements, perform protocol-specified procedures, or adhere to the diet and activity restrictions;\n30. Belonging to a vulnerable group of volunteers: students of higher and secondary medical, pharmaceutical, and dental educational institutions; subordinate clinical or laboratory staff; employees of pharmaceutical companies; military personnel and prisoners; residents of long-term care facilities; low-income and unemployed individuals; representatives of national minorities; homeless individuals; refugees; individuals under guardianship or trusteeship; persons incapable of providing informed consent; as well as law enforcement officers;\n31. Any other condition which, in the Investigator's judgment, would preclude the subject's enrollment in the study or could lead to premature withdrawal, including adherence to fasting practices or special diets (e.g., vegetarian, vegan, sodium-restricted) or lifestyle factors (e.g., night shift work, extreme physical exertion).\n\nExclusion criteria:\n\n1. Subject's decision to discontinue participation in the study;\n2. Subject non-compliance with protocol requirements, including but not limited to missed study procedures, unauthorized use of prohibited concomitant medications, or failure to adhere to protocol-defined dietary and lifestyle restrictions.\n3. Occurrence of any medical condition or safety concern during study participation that could compromise subject safety (e.g., hypersensitivity reactions, etc.);\n4. Subjects enrolled in the study despite not meeting eligibility criteria (inclusion\u002Fexclusion criteria violations).\n5. Prolongation of the QTcF interval on ECG recording (\\>500 ms or \\>60 ms compared to baseline measured on Days 1, 8, 15, and 22);\n6. Occurrence of a severe adverse event (AE) and\u002For serious adverse event (SAE) during study participation\n7. Missed collection of two or more consecutive blood samples for pharmacokinetic analysis or three or more samples within one pharmacokinetic study period;\n8. The volunteer is receiving or requires treatment that may affect the pharmacokinetic parameters of the study drug;\n9. Occurrence of vomiting\u002Fdiarrhea within 8 hours after administration of the study drug;\n10. Positive urine test for narcotic substances and potent medicinal products;\n11. Positive breath alcohol test;\n12. Positive urine β-hCG test result in women;\n13. Emergence of any other reason during study participation that, in the Investigator's judgment, precludes the subject's continued compliance with protocol requirements.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study aims to evaluate the safety and pharmacokinetic profile of the active ingredients Ingavirin forte, capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) relative to single-entity Drug Ingavirin, capsules, 90 mg following administration under fasting and fed conditions.",[28,29],"Influenza","Acute Respiratory Viral Infections","RECRUITING","2026-06-11",{"date":33,"type":34},"2026-06-12","ACTUAL",{"date":36,"type":34},"2025-07-11",{"date":38,"type":22},"2027-12-31",{"name":40,"class":41},"Valenta Pharm JSC","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":42},"100642272","phase-1-food-effect-single-and-multiple-dose-pharmacokinetics-safety-and-tolerability-study-of-4-must-128-mg-tablets-in-healthy-volunteers-100642272","NCT07594977","Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers","An Open-Label Study to Evaluate the Effect of Food on the Bioavailability of 4-MUST, 128 mg, Tablets and to Assess the Pharmacokinetics, Safety, and Tolerability Following Single and Multiple Dose Administration in Healthy Volunteers","Inclusion Criteria:\n\n* Voluntary, personally signed ICF obtained prior to any study procedures;\n* Males and females aged 18 to 45 years (inclusive) of Caucasian race;\n* Confirmed healthy status based on the absence of clinically significant abnormalities in clinical, laboratory, and diagnostic assessments specified in the protocol;\n* Blood pressure (BP): systolic blood pressure (SBP) from 99 to 129 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mmHg (inclusive);\n* Heart rate (HR) from 60 to 89 beats\u002Fmin (inclusive);\n* Respiratory rate (RR) from 12 to 20 per 1 minute (inclusive);\n* Body temperature from 36.0°C to 36.9°C (inclusive);\n* Body mass index (BMI) of 18.5 kg\u002Fm2 ≤ BMI ≤ 30 kg\u002Fm2, with body weight ≥ 55 kg for males and ≥ 45 kg for females;\n* Commitment to adhere to highly effective contraceptive methods during the study participation period and for 30 days thereafter; documentation of negative urine pregnancy test for women of childbearing potential.\n\nNoninclusion Criteria:\n\n* History of clinically significant allergic reactions;\n* Hypersensitivity to hymecromone and trimebutine and\u002For excipients included in the study drug in anamnesis;\n* Drug intolerance to hymecromone and trimebutine and\u002For excipients included in the study drug in the anamnesis;\n* Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption in the anamnesis;\n* Chronic diseases of the kidney, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary and immune systems, as well as skin, hematopoietic and visual organs;\n* History of GI surgery (except for appendectomy at least 1 year prior to screening);\n* Diseases\u002Fconditions that, in the opinion of the investigator, may affect the absorption, distribution, metabolism, or excretion of the study drug;\n* Acute infectious diseases less than 4 weeks prior to screening;\n* Intake of drugs that have a significant effect on hemodynamics and drugs that affect liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening;\n* Regular intake of a medicine less than 2 weeks prior to screening and single intake of a medicine less than 7 days prior to screening (including over-the-counter medicines, vitamins, supplements, herbs);\n* Blood or plasma donation less than 3 months prior to screening;\n* Use of hormonal contraceptives (in women) less than 2 months prior to screening;\n* Use of depot injections of any medicine less than 3 months prior to screening;\n* Pregnancy or lactation period; positive pregnancy test for women of childbearing potential;\n* Women of childbearing potential who have had unprotected sexual intercourse with a non-sterilized male partner within 30 days prior to administration of the study drug;\n* Participation in another clinical trial less than 3 months prior to screening or concurrent with the present study;\n* Consumption of more than 10 units of alcohol per week during the month prior to study enrollment (1 unit of alcohol is equivalent to 500 mL of beer, 200 mL of wine, or 50 mL of spirits), or a history of alcoholism, drug dependence, or abuse of medicinal products;\n* Smoking more than 10 cigarettes per day currently, or a history of smoking the indicated number of cigarettes in the 6 months preceding screening; failure to agree to abstain from smoking for the duration of the hospital stay;\n* Consumption of alcohol, caffeine, and xanthine-containing products in the 7 days prior to taking the study drug;\n* Consumption of citrus fruits, cranberries, rose hips and products containing them, preparations or products containing St. John's wort - 7 days before taking the study drug;\n* Dehydration due to diarrhea, vomiting, or other cause within the last 24 hours prior to taking the study drug;\n* Positive blood test result for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens at screening;\n* Clinically significant abnormalities on electrocardiogram (ECG) in the medical history and\u002For at screening;\n* Positive urinalysis for narcotics and potent drugs at screening;\n* Positive breath alcohol vapor test at screening;\n* Scheduling a hospital stay during the study period, for any reason other than hospitalization required by this protocol;\n* Failure or inability to comply with protocol requirements, follow protocol procedures, diet and activity regimen.\n* Belonging to a vulnerable population, including: students enrolled in medical, pharmaceutical, or dental educational institutions, clinical and laboratory assistants, pharmaceutical company employees, military personnel and prisoners, persons residing in residential care facilities, low-income and unemployed, minorities, homeless, vagrants, refugees, persons in foster care, persons unable to consent, and law enforcement officers;\n* Any other condition that, in the judgement of the Investigator, would preclude the volunteer's enrollment in the study or could lead to premature withdrawal from the study, including adherence to fasting regimens or special diets (e.g., vegetarian, vegan, or sodium-restricted diets) or lifestyle factors (e.g., night-shift work or extreme physical exertion)\n\nExclusion criteria:\n\n* Voluntary withdrawal of the subject from the study;\n* Failure to comply with protocol requirements by the volunteer (e.g., missing scheduled study procedures, unauthorized use of prohibited medications, or violation of dietary or lifestyle restrictions);\n* Occurrence of any event or condition during the study that, in the investigator's judgement, may compromise the volunteer's safety (e.g., hypersensitivity reactions);\n* Volunteers selected for participation in the study in violation of the inclusion\u002Fnon-inclusion criteria;\n* Development of severe adverse event and\u002For a serious adverse event in a volunteer during the course of the study;\n* Volunteer is receiving or requires treatment that may affect the pharmacokinetic parameters of the study drug;\n* Missing collection of 2 or more consecutive blood samples or 3 x or more blood samples during the same Study Period;\n* Occurrence of vomiting\u002Fdiarrhea within 6 h after administration of study drug;\n* Positive urine test for narcotics and potent drugs;\n* Positive breath alcohol test;\n* Positive pregnancy test in women;\n* Occurrence of any other circumstance that precludes conduct of the study in accordance with the protocol.",{"count":51,"type":22},45,[25],"This open-label study will evaluate the effect of food on the bioavailability of a single dose of 4-MUST, tablets, 128 mg. Additionally, the study will assess the pharmacokinetics, safety, and tolerability of 4-MUST, tablets, 128 mg following both single and multiple oral dose administration.",[55,56],"Chronic Cholecystitis","Biliary Dyskinesia","2026-06-10",{"date":59,"type":34},"2026-06-15",{"date":61,"type":34},"2026-01-26",{"date":63,"type":22},"2027-06-30",{"name":40,"class":41},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":85,"locationsCount":86},"100637195","phase-3-efficacy-safety-and-tolerability-of-4-must-128-mg-tablets-in-chronic-cholecystitis-and-biliary-dyskinesia-100637195","NCT07595003","Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Chronic Cholecystitis and Biliary Dyskinesia","Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Patients With Chronic Cholecystitis and Biliary Tract Dyskinesia","Inclusion Criteria:\n\n1. Males and females aged 18-70 years.\n2. Diagnosed with chronic cholecystitis (K81.1) and\u002For dyskinesia of the cystic duct or gallbladder (K82.8) prior to enrollment; diagnosis supported by clinical history of exacerbations and remissions and\u002For imaging\u002Flaboratory findings.\n3. Upper abdominal pain or discomfort attributable to gallbladder or biliary tract dysfunction (per investigator assessment), accompanied by ≥1 of the following: heartburn, belching, nausea, abdominal bloating, borborygmi (stomach rumbling), flatulence, constipation, or diarrhea.\n4. Maximum severity of pain\u002Fdiscomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).\n5. Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.\n6. The total bilirubin level does not exceed 2 times the upper limit of normal (no more than 42 μmol\u002FL).\n7. Women who are either sexually abstinent or using effective contraception methods (e.g. intrauterine devices, contraceptive patches, long-acting injectable contraceptives, or double barrier methods) for at least 8 weeks before and 3 weeks after the end of the study, with a confirmed negative pregnancy test, as well as women with documented infertility or non-childbearing status (e.g. hysterectomy, tubal ligation, infertility or menopause for more than 1 year) or men using barrier contraceptives throughout the study and for 3 weeks after its completion, or men unable to conceive (documented conditions: vasectomy, infertility).\n8. Signed and dated informed consent from.\n\nNon-inclusion Criteria:\n\n1. Gastric or duodenal ulcer, erosive gastroesophageal reflux disease (GERD), or other inflammatory\u002Ferosive gastrointestinal diseases in the acute stage, unless stable remission for ≥ 1 year since the last exacerbation.\n2. Indication for surgical or endoscopic intervention due to exacerbation of chronic cholecystitis or complications of biliary tract dyskinesia.\n3. Toxic megacolon.\n4. Paralytic ileus.\n5. Gilbert's syndrome.\n6. Choledocholithiasis (or a high risk of its development, as determined by the investigator);\n7. Impaired bile outflow due to adhesions in the abdominal cavity.Abdominal adhesion disease.\n8. Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.\n9. Gastrointestinal malignancy (including history of) or suspected gastrointestinal malignancy (e.g., blood in stool, unexplained weight loss, fever, anemia).\n10. Any other oncological diseases known at the time of screening, or suspicion thereof.\n11. History of gastrointestinal surgery, including cholecystectomy or endoscopic sphincterotomy (appendectomy excluded).\n12. Use of prohibited therapy medications within 3 days prior to randomization.\n13. History of mental illnesses.\n14. Chronic heart failure IIb-III stages and\u002For III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.\n15. Chronic kidney disease stage IIIa-V (according to NKF\u002FKDOQI, 2006).\n16. History of or current hepatic impairment; or liver test abnormalities: AST, ALT, ALP, or GGT \\>3 above the upper limit of normal (ULN); total bilirubin \\>2 ULN or clinical jaundice.\n17. HIV, syphilis, viral hepatitis B or C, including in history.\n18. Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.\n19. Liver cirrhosis.\n20. Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.\n21. Severe, decompensated, or unstable somatic conditions that are life-threatening, worsen prognosis, or preclude safe study participation.\n22. Diabetes mellitus in a state of subcompensation and decompensation.\n23. Systemic connective tissue diseases.\n24. Autoimmune diseases.\n25. Indication for hemodialysis procedures.\n26. Epilepsy or seizures of unclear etiology, including in history.\n27. Alcoholism, substance abuse or drug addiction, including in history.\n28. Uncorrected electrolyte disturbances.\n29. QTcF interval on a 12-lead electrocardiogram (ECG) ≥430 ms in men and ≥450 ms in women.\n30. Episodes of constipation during the last 3 months that required the prescription of drug therapy.\n31. History of surgery within 6 month prior to screening.\n32. Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.\n33. Patients who require prohibited concomitant therapy within this study framework.\n34. Participation in another clinical trial within the last 3 months prior to the screening visit date.\n35. Unwillingness or inability to comply with study procedures and protocol requirements..\n36. Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.\n\nExclusion Criteria:\n\n1. Incorrect enrollment of a patient in the study (failure to meet inclusion\u002Fexclusion criteria at the time of randomization).\n2. Lack of Efficacy. Study treatment will be discontinued if no clinical improvement is observed by Visit 3 (Day 15 ± 1), defined as persistence or worsening of upper abdominal pain\u002Fdiscomfort (assessed by Visual Analog Scale \\[VAS\\]) compared to baseline. Upon discontinuation, alternative therapy will be initiated at the investigator's discretion.\n3. Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).\n4. Requirement for prohibited concomitant therapy.\n5. Use of Duspatalin® (INN: mebeverine) for more than 3 consecutive days or for more than 5 days in total throughout the study.\n6. If the investigator judges that comtinued participation in the study would harm the patient.\n7. Pregnancy or the need for breastfeeding.\n8. Major protocol deviation by the subject with respect to procedures outlined in the Informed Consent Form (ICF).\n9. Withdrawal of informed consent by the subject (decision to discontinue study participation).\n10. Lost to follow-up: Inability to contact the subject after ≥3 documented attempts via mobile phone, landline (if applicable), and designated emergency contact.\n11. Emergence during the study of any diseases or conditions that worsen the patient's prognosis, making it impossible for the patient to continue participating in this clinical trial.\n12. Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.","70 Years",{"count":74,"type":22},300,[76],"PHASE3","The aim of the study is to evaluate the efficacy, safety, and tolerability of 4-MUST, 128 mg tablets compared to placebo in patients with chronic cholecystitis and biliary dyskinesia.",[55,56],"2026-05-12",{"date":81,"type":34},"2026-05-19",{"date":83,"type":34},"2025-12-12",{"date":38,"type":22},{"name":40,"class":41},10,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":107,"locationsCount":108},"100625311","phase-2-study-to-evaluate-the-efficacy-safety-and-tolerability-of-the-ingavirin-forte-capsules-valenta-pharm-jsc-at-different-doses-in-subjects-with-influenza-and-other-acute-respiratory-viral-infections-100625311","NCT07420985","Study to Evaluate the Efficacy, Safety, and Tolerability of the Ingavirin Forte Capsules (Valenta Pharm JSC) at Different Doses in Subjects With Influenza and Other Acute Respiratory Viral Infections.","A Multicenter, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of the Investigational Product Ingavirin Forte Capsules (Valenta Pharm JSC) at Different Doses in Subjects With Influenza and Other Acute Respiratory Viral Infections.","Inclusion Criteria:\n\n1. Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;\n2. Males and females aged 18 to 65 years (inclusive) at the time of signing the ICF;\n3. Subjects with influenza or other acute respiratory viral infections confirmed by polymerase chain reaction (PCR);\n4. Presence of clinically significant signs of influenza or acute respiratory viral infections at screening:\n\n   * Body temperature \\>38,0 °С at randomization, with no intake NSAID within 12 hours before randomization;\n   * Presence of at least two of the following symptoms of influenza or other acute respiratory viral infections (cough, rhinorrhea, sore throat, or a throat irritation) each rated non less than 6 points on a numeric rating scale (NRS);\n   * Presence of at least one of the following systemic manifestations of influenza or other acute respiratory viral infections (headache, myalgia, or general weakness) rated non less than 6 points on a numeric rating scale (NRS).\n5. Duration of illness from symptoms onset to administration of the first dose of investigational medical product or comparator is ≤ 48 hours;\n6. No clinical indications for hospitalization at the time of study enrollment;\n7. Consent to use adequate contraceptive methods throughout the study and for 30 days after study completion. The follwing subjects are eligible for inclusion in the study:\n\n   * Females of childbearing potential must have a negative pregnancy test and use one of the folliwing adequate contraceptive methods: sexual abstinence, condom combined with spermicide or hormonal contraceptives, contraceptive subdermal implant, intrauterine hormonal system, intrauterine device. Females not of childbearing potential (i.e., with a history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, comfirmed infertility, or ≥ 2 of menopause) are also eligible for participation;\n   * Males with reptoductive potential must use one of the folliwing adequate contraceptive methods: sexual abstinence, condom combined with spermicide or hormonal contraceptives. Males with infertility or a history of vasectomy are also eligible for participation;\n\nExclusion Criteria:\n\n1. Clinically significant allergic history;\n2. Hypersensitivity to active substances of medical produtcs Ingavirin and Ingavirin forte, and\u002For to any excipient contaned in the investigational medicinal product or comparator;\n3. Intolerance to active substances of medical produtcs Ingavirin and Ingavirin forte, and\u002For to any excipient contaned in the investigational medicinal product or comparator;\n4. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;\n5. Clinical suspicion of pneumonia of any etiology, or other bacterial infection (e.g. sinusitis, otitis media, urinary tract infection, meningitis, sepsis) requiring initiation for antibacterial therapy;\n6. Nasal obstruction due to structural pathology, such as sequelae of nasal trauma, nasal polyps, septal deviation, or other organic causes;\n7. History of vasomotor rhinitis;\n8. Administration of antibiotics, antiviral (including Ingavirin), or immunomodulatory agents within 48 hours prior to study, and\u002For anticipated need for any of these agents during the study;\n9. Vaccination within 90 days prior to study enrollment;\n10. Uncontrolled diabetes mellitus;\n11. Obesity, class II or III (body mass index ≥35 kg\u002Fm²);\n12. Pregnancy or lactation;\n13. Positive test for SARS-CoV-2 at screening;\n14. History of autoimmune diseases;\n15. Current or past HIV, syphilis, hepatitis B and\u002For C, or tuberculosis;\n16. Known or suspected history of alcohol, psychotropic drug, or substance abuse or dependence;\n17. History of chronic respiratory disease, including but not limited to: chronic obstructive pulmonary disease (COPD), asthma, chronic bronchitis, diffuse panbronchiolitis, pulmonary emphysema, or pulmonary fibrosis;\n18. Chronic heart failure, New York Heart Association (NYHA) functional class III or IV;\n19. Current or past psychiatric disoder;\n20. Any clinically significant cardiovascular, renal, hepatic, gastrointestinal , endocrine, or neurological disoder, including severe uncompensated chronic conditions (e.g., chronic kidney disease, chronic liver disease) or acute illness, or any other medical or psychiatric condition that, in investigator's opinion, could pose a safety risk to the subject if they participate in the study;\n21. Subject's refusal to use an adequate method of contraception or to practice continuous sexual abstinence throughout the study and for 30 days after study completion;\n22. Participation in another clinical trial within 3 months prior to screening;\n23. Other conditions which, in the judgment of the investigator, could compromise the subject's participation in the study or pose an undue risk.\n\nExclusion Criteria:\n\n1. Subject's decision to withdraw from the study (withdrawal of informed consent);\n2. Investigator's decision to discontinue the subject from the study in the subject's best interest;\n3. Investigator-determined need for a concomitant therapy explicitly prohibited by the protocol of clinical study;\n4. Subject's use of a therapy prohibited by the protocol;\n5. Positive urine test for beta-human chorionic gonadotropin (β-hCG) in females of childbearing potential;\n6. Lack of adequate cooperation by the subject with the investigator during the study;\n7. Emergence during the study of conditions or events that jeopardize subject safety (e.g., hypersensitivity reactions, serious adverse events \\[SAEs\\]) or, in the investigator's medical judgment, worsen the subject's prognosis or preclude further participation in the clinical study;\n8. Incorrect inclusion of a subject who does not meet the protocol-specified inclusion and\u002For exclusion criteria;\n9. Major deviation from the treatment regimen, defined as:\n\n   * Missing two or more consecutive doses of the investigational medicinal product (IMP) or comparator;\n   * Total intake of fewer than 80% or more than 120% of the planned total number of capsules (full course includes 10 capsules);\n10. Confirmed diagnosis of COVID-19;\n11. Occurrence during the study of any other condition that precludes adherence to the protocol;\n12. Subject's death.","65 Years",{"count":74,"type":22},[97],"PHASE2","The objective of this study is to investigate the efficacy, safety, and tolerability of investigational product Ingavirin forte capsules (Valenta Pharm JSC) administered at different doses compared with medicinal product Ingavirin, 90 mg, capsules (Valenta Pharm JSC) in subjects with influenza or other acute respiratory viral infections (ARVIs).",[28,100],"Acute Respiratory Viral Infection","2026-02-11",{"date":103,"type":34},"2026-02-19",{"date":105,"type":34},"2025-10-24",{"date":38,"type":22},{"name":40,"class":41},11,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":42},"100625313","phase-1-pharmacokinetics-bioequivalence-and-safety-study-of-trimedat-7695-mg-orally-disintegrating-tablets-and-trimedat-100-mg-tablets-in-healthy-volunteers-100625313","NCT07421011","Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.","A Randomized, Open-label, Crossover Study to Assess the Comparative Pharmacokinetics, Bioequivalence, and Safety of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.","Inclusion Criteria:\n\n1. Voluntarily and personally signed informed consent form by a healthy volunteer obtained prior to the conduct of any study-related procedure;\n2. Males and females aged 18 to 45 years (inclusive) of Caucasian race.;\n3. Verified healthy status as demonstrated by the absence of clinically significant abnormalities in medical history, physical and instrumental examination, laboratory tests, and other diagnostic procedures specified in the protocol;\n4. Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 130 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mm Hg (inclusive);\n5. Heart rate (HR) from 60 to 89 beats per minute (inclusive);\n6. Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive);\n7. Body temperature from 36.0°C to 36.9°C (inclusive);\n8. Body mass index (BMI) between 18.5 kg\u002Fm² and 30 kg\u002Fm², with a minimum body weight of ≥ 55 kg for men and ≥ 45 kg for women;\n9. Consent to use adequate contraceptive methods throughout the study and for 30 days after its completion, with a negative urine pregnancy test result for women of childbearing potential.\n\nNon-Inclusion Criteria:\n\n1. Clinically significant allergic history;\n2. Hypersensitivity to active and\u002For excipient substances in the investigational drug and comparator drug in the medical history;\n3. Drug intolerance to active and\u002For excipient substances in the investigational drug and comparator drug in the medical history;\n4. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;\n5. Chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, and immune systems, as well as skin, hematopoietic organs, and the eye;\n6. Surgical interventions on the GIT in the medical history (except for appendectomy performed at least 1 year prior to screening);\n7. Diseases\u002Fconditions that, in the investigator's judgment, may affect the absorption, distribution, metabolism, or excretion of the investigational drugs;\n8. Acute infectious diseases less than 4 weeks before screening;\n9. Use of drugs that significantly affect hemodynamics and drugs affecting liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening;\n10. Regular use of medications less than 2 weeks before screening and single use of medications less than 7 days before screening (including over-the-counter drugs, vitamins, dietary supplements, herbal medicines);\n11. Blood or plasma donating within 3 months prior to screening;\n12. Use of hormonal contraceptives (in women) within 2 months prior to screening;\n13. Use of depot injections of any medications within 3 months prior to screening;\n14. Pregnancy or lactation; positive urine pregnancy test result for women of childbearing potential;\n15. Female subjects of childbearing potential who had unprotected sexual intercourse with an unsterilized male partner within 30 days prior to administration investigational drugs;\n16. Participation in another clinical study within 3 months prior to screening or concurrently with this study;\n17. Consumption of more than 10 alcohol units per week (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of wine, or 50 ml of strong alcoholic beverages) in the last month before inclusion in the study or a history of alcoholism, drug addiction, or substance abuse;\n18. Smoking more than 10 cigarettes per day currently or smoking that amount in the past 6 months prior to screening; unwillingness to refrain from smoking during hospitalization;\n19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to taking investigational drugs;\n20. Consumption of citrus fruits, cranberries, rose hips and products containing them, or preparations\u002Fproducts containing St. John's wort within 7 days prior to taking investigational drugs;\n21. Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours prior to taking investigational drugs;\n22. Positive blood test for antibodies to human immunodeficiency virus (HIV) types 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens during screening;\n23. ECG abnormalities in medical history and\u002For during screening;\n24. Positive urine test for narcotic substances and potent medications during screening;\n25. Positive breath alcohol test result during screening;\n26. Planning hospitalization during the study period for any reason other than hospitalization specified in the study protocol;\n27. Inability or unwillingness to comply with protocol requirements, perform procedures prescribed by the protocol, or adhere to dietary and activity restrictions;\n28. Membership in a vulnerable population, including but not limited to students of medical, pharmaceutical and dental educational institutions, junior staff of clinics and laboratories, employees of pharmaceutical companies, military personnel, prisoners, residents of care facillities, individuals with low income or unemployed, members of ethnic minorities, homeless persons, vagrants, refugees, individuals under guardianship or conservatorship, individuals unable to provide informed consent and law enforcement personnel;\n29. Other conditions that in the judgment of the Investigator may prevent volunteer inclusion in the study or lead to premature withdrawal from the study including adherence to fasting or special diets (e.g., vegetarianism, veganism, salt restriction) or special lifestyles (night work, extreme physical exertion).\n\nExclusion Criteria:\n\n1. Withdrawal of the volunteer from further participation in the study;\n2. Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);\n3. Emergence of reasons\u002Fsituations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);\n4. Volunteers selected for participation in the study who do not meet inclusion\u002Fexclusion criteria;\n5. Development of a severe and\u002For serios adverse event (AE\u002FSAE) in the volunteer during the study;\n6. The volunteer undergoes or requires treatment that may affect the pharmacokinetic parameters (PKP) of the investigational drugs;\n7. Missed collection of 2 or more consecutive blood samples or 3 or more blood samples within one study period;\n8. Occurrence of vomiting\u002Fdiarrhea within 6 hours after taking the investigational drug;\n9. Positive urine test for narcotic substances and potent medications;\n10. Positive breath test for alcohol vapors;\n11. Positive pregnancy test result in women;\n12. Emergence of other circumstances during the study that preclude conducting the study according to the protocol.",{"count":21,"type":22},[25],"This study aims to evaluate pharmacokinetic profile, safety and establish bioequivalence of the investigational drug Trimedat® 76,95 mg orally disintegrating tablets compared to the reference drug Trimedat® 100 mg tablets in healthy volunteers under fasted conditions.",[120,121,122,56,123],"Irritable Bowel Syndrome","Gallstone Disease","GERD","Postcholecystectomy Syndrome",{"date":103,"type":34},{"date":126,"type":34},"2025-11-06",{"date":128,"type":22},"2026-12-31",{"name":40,"class":41},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":146,"locationsCount":147},"100580873","phase-2-efficacy-safety-and-tolerability-of-4-must-tablets-in-chronic-cholecystitis-and-biliary-dyskinesia-100580873","NCT06842966","Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia","A Prospective Multicenter Randomized Double-blind Placebo-controlled Study in Parallel Groups to Evaluate the Efficacy, Safety, and Tolerability of the Drug 4-MUST, Tablets, 128 mg Administered at Various Doses in Patients With Chronic Cholecystitis and Biliary Dyskinesia","Inclusion Criteria:\n\n1. Males and females aged 18-70 years.\n2. Presence of established gastrointestinal diseases: Chronic cholecystitis (K81.1); Dyskinesia of the bile duct or gallbladder (K82.8).\n3. Presence of pain\u002Fdiscomfort in the upper abdomen combined with at least one of the following symptoms: Heartburn; Belching; Nausea; Abdominal bloating; Borborygmi (stomach rumbling); Flatulence; Constipation; Diarrhea.\n4. Maximum severity of pain\u002Fdiscomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).\n5. Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.\n6. Women who are either sexually abstinent or using effective contraception methods (e.g. intrauterine devices, contraceptive patches, long-acting injectable contraceptives, or double barrier methods) for at least 8 weeks before and 3 weeks after the end of the study, with a confirmed negative pregnancy test, as well as women with documented infertility or non-childbearing status (e.g. hysterectomy, tubal ligation, infertility or menopause for more than 1 year) or men using barrier contraceptives throughout the study and for 3 weeks after its completion, or men unable to conceive (documented conditions: vasectomy, infertility).\n7. Signed and dated informed consent from.\n\nNon-inclusion Criteria:\n\n1. Peptic ulcer disease, duodenal ulcer, erosive GERD.\n2. Toxic megacolon.\n3. Paralytic ileus.\n4. Gilbert's syndrome.\n5. Abdominal adhesion disease.\n6. Blood in stool, unexplained weight loss, fever, anemia.\n7. Inflammatory and erosive gastrointestinal diseases.\n8. Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.\n9. Oncological diseases of the gastrointestinal tract (including past diagnoses).\n10. History of gastrointestinal surgical procedures, including but not limited to endoscopic papillotomy and cholecystectomy, exept for appendectomy.\n11. Use of prohibited therapy medications within 3 days prior to randomization.\n12. History of mental illnesses.\n13. Chronic heart failure IIb-III stages and\u002For III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.\n14. Chronic kidney disease stage IIIa-V (according to NKF\u002FKDOQI, 2006).\n15. Established diagnosis of liver failure, including in history and\u002For changes in liver enzyme activity: Increase in AST, ALT, ALP and\u002For γ-GTP more than 3 times above the upper limit of normal; Increase in total bilirubin more than 2 times above the upper limit of normal or development of jaundice.\n16. HIV, syphilis, viral hepatitis B or C, including in history.\n17. Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.\n18. Liver cirrhosis.\n19. Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.\n20. Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen their prognosis and make it impossible for the patient to participate in clinical research).\n21. Diabetes mellitus in a state of subcompensation and decompensation.\n22. Systemic connective tissue diseases.\n23. Autoimmune diseases.\n24. Need for surgical and\u002For endovascular treatment and\u002For necessity for hemodialysis procedures.\n25. Epilepsy or seizures of unclear etiology, including in history.\n26. Alcoholism, substance abuse or drug addiction, including in history.\n27. Uncorrected electrolyte disturbances.\n28. History of surgery within 6 month prior to screening.\n29. Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.\n30. Patients who require prohibited concomitant therapy within this study framework.\n31. Participation in another clinical trial within the last 3 months prior to the screening visit date.\n32. Lack of willingness to cooperate from the patient's side.\n33. Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.\n\nExclusion Criteria:\n\n1. Incorrect enrollment of a patient in the study (failure to meet inclusion\u002Fexclusion criteria at the time of randomization).\n2. Ineffectiveness of therapy. The therapy will be deemed ineffective if there is no clinical improvement by visit 3 (15±1 days of therapy) - persistence or increase in the severity of pain\u002Fdiscomfort in the upper abdomen on the VAS compared to baseline. If excluded, the patient will be assigned alternative treatment at the discretion of the investigator.\n3. Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).\n4. Requirement for prohibited concomitant therapy.\n5. If the investigator judges that comtinued participation in the study would harm the patient.\n6. Pregnancy or the need for breastfeeding in the patient.\n7. Gross violation by the patient of the study protocol procedures outlined in the patient information sheet (PIS).\n8. Withdrawal of informed consent (patient's unwillingness to continue participation in the study).\n9. Loss of contact with the patient (inability to reach the patient via mobile and home phone (if applicable), as well as through a contact person; there must be at least three documented attempts to contact the patient).\n10. Emergence during the study of any diseases or conditions that worsen the patient's prognosis, making it impossible for the patient to continue participating in this clinical trial.\n11. Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.",{"count":74,"type":22},[97],"This study aims to evaluate the efficacy, safety, and tolerability of the drug 4-MUST at various doses compared to placebo in patients with chronic cholecystitis and biliary dyskinesia",[55,56],"2025-07-07",{"date":36,"type":34},{"date":144,"type":34},"2024-10-17",{"date":128,"type":22},{"name":40,"class":41},17,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":170,"locationsCount":171},"100580877","phase-2-study-to-evaluate-the-efficacy-and-safety-of-different-doses-of-graminidin-with-anesthetic-a-metered-dose-topical-spray-in-the-treatment-of-acute-infectious-and-inflammatory-pharyngeal-diseases-compared-with-drug-septolete-total-lozenges-100580877","NCT06843018","Study to Evaluate the Efficacy and Safety of Different Doses of Graminidin With Anesthetic, a Metered Dose Topical Spray, in the Treatment of Acute Infectious and Inflammatory Pharyngeal Diseases Compared With Drug Septolete Total, Lozenges","A Prospective, Open-label, Multicenter, Comparative, Randomised, Parallel-group Study to Evaluate the Efficacy and Safety of Different Doses of the Drug Graminidin With Anesthetic, a Metered Dose Topical Spray, in the Treatment of Acute Infectious and Inflammatory Pharyngeal Diseases Compared With Drug Septolete Total, Lozenges","Inclusion Criteria:\n\n1. Male or female patients aged 18 to 75 years inclusive.\n2. Symptom \"sore throat\" due to infectious-inflammatory diseases of the pharynx (acute pharyngitis, acute nasopharyngitis, exacerbation of chronic pharyngitis) based on one or more of the following clinical manifestations:\n\n   * Unpleasant sensations\u002Fdiscomfort in the throat - symptoms of pharyngeal paresthesia (scratchy throat, dryness or sore sensation (\"foreign body\" sensation));\n   * Painful sensations in the throat, including sore throat at rest, throat burning, or pain upon swallowing saliva;\n3. Severity of the symptom \"sore throat\" from 55 mm to 80 mm on the Visual Analog Scale (VAS).\n4. A score of 5 to 8 points on the Clinical Symptom Severity Scale for tonsillopharyngitis.\n5. Absence of indications for systemic antibacterial therapy at the time of inclusion in the study.\n6. Negative test result for β-hemolytic streptococcus.\n7. Duration of disease symptoms not exceeding 3 days at the time of inclusion in the study.\n8. Women with a negative pregnancy test who have used one or more of the following contraceptive methods for 8 weeks prior to and during the 3 weeks after the end of the study: intrauterine devices (IUDs), oral contraceptives, contraceptive patches, long-acting injectable contraceptives, double barrier contraceptive method; or women who are infertile (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year); or men using a double barrier contraceptive method (condom with spermicide) throughout the study and for 3 weeks after its conclusion or men who are infertile (documented conditions: vasectomy, infertility).\n9. Signed and dated informed consent form.\n\nNon-inclusion Criteria:\n\n1. Trauma and\u002For burns of the oropharynx, scarlet fever, rubella, measles at the time of inclusion in the study and not earlier than 3 months before inclusion in the study.\n2. Treatment with any systemic antibacterial agents within 14 days prior to inclusion in the study.\n3. Use of non-steroidal anti-inflammatory drugs and\u002For decongestants within 12 hours prior to the randomization visit.\n4. Body temperature at screening and randomization visits ≥ 38.5 °C.\n5. Infectious-inflammatory diseases requiring combined or systemic antibacterial therapy.\n6. Severe, decompensated, or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the prognosis of the underlying disease, as well as make it impossible for the patient to participate in the clinical study).\n7. History of malignancy, exept for subjects who have been disease-free for at least 5 years prior to screening.\n8. Allergic history.\n9. Participation in any other clinical study within 90 days prior to inclusion in the study.\n10. Pregnancy or breastfeeding in women.\n11. Refusal to use effective contraceptive methods during the study.\n12. Alcoholism, drug addiction, abuse of psychotropic medications, including in history.\n13. Smoking more than 10 cigarettes per day.\n14. Positive urine test for narcotic substances and potent medications.\n15. Vaccination within 21 days prior to study enrollment.\n16. Other conditions that, in the opinion of the investigator, prevent the patient from being included in the study.\n\nExclusion Criteria:\n\n1. Erroneous inclusion of a patient in the study (not meeting inclusion\u002Fexclusion criteria at the time of randomization).\n2. Ineffectiveness of therapy. Therapy will be considered ineffective if there is no clinical improvement by Visit 2 (Day 3-4 of therapy) - persistence or worsening of the symptom \"sore throat\" and catarrhal phenomena compared to baseline data. If excluded, the patient will be assigned alternative treatment at the discretion of the investigator.\n3. Patient non-compliance (a patient is considered compliant if the number of applications of the study drug\u002Fcomparison drug is not less than 17 and not more than 25).\n4. Smoking more than 10 cigarettes per day.\n5. Requirement for prohibited concomitant therapy.\n6. The investigator determines that continued participation in the study may pose a risk to the subject's safety or well-being.\n7. Pregnancy or breastfeeding.\n8. Gross violation by the patient of the study protocol procedures presented in the patient information sheet (PIS).\n9. Withdrawal of informed consent (the patient's unwillingness to continue participation in the study).\n10. Loss of contact with the patient (inability to reach the patient by mobile and home phone (if applicable), as well as through a contact person; there must be at least three documented attempts to contact the patient).\n11. The emergence during the study of any diseases or conditions that worsen the patient's prognosis and make it impossible for the patient to continue participating in this clinical study.\n12. Any other reasons, including administrative ones, that in the investigator's judgment would prevent the subject from completing the study.","75 Years",{"count":74,"type":22},[97],"This study aims to evaluete of tthe efficacy and safety of using different doses of the drug Grammidin with anesthetic, a metered dose topical spray, in the treatment of acute infectious and inflammatory pharyngeal diseases.",[160,161,162,163],"Pharyngitis Acute","Pharyngitis","Nasopharyngitis","Exacerbation of Chronic Pharyngitis","2025-07-04",{"date":166,"type":34},"2025-07-10",{"date":168,"type":34},"2024-11-14",{"date":128,"type":22},{"name":40,"class":41},12,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":42},"100582128","phase-1-safety-tolerability-and-pharmacokinetic-profile-of-grammidin-a-metered-dose-topical-spray-in-healthy-volunteers-100582128","NCT06859281","Safety, Tolerability, and Pharmacokinetic Profile of Grammidin, a Metered Dose Topical Spray in Healthy Volunteers","An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of the Drug Grammidin, a Metered Dose Topical Spray Following Single Administration in Healthy Volunteers","Inclusion Criteria:\n\n1. Voluntarily and personally signed informed consent form by a healthy volunteer obtained prior to the conduct of any study-related procedure;\n2. Males and females aged 18 to 45 years (inclusive);\n3. Verified healthy status as demonstrated by the absence of clinically significant abnormalities in medical history, physical examination, laboratory tests, and other diagnostic procedures specified in the protocol;\n4. Blood pressure (BP) level: systolic blood pressure (SBP) from 99 to 129 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 89 mm Hg (inclusive);\n5. Heart rate (HR) from 60 to 89 beats per minute (inclusive);\n6. Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive);\n7. Body temperature from 36.0°C to 36.9°C (inclusive);\n8. Body mass index (BMI) between 18.5 kg\u002Fm² and 30 kg\u002Fm², with a minimum body weight of ≥ 55 kg for men and ≥ 45 kg for women;\n9. Consent to use adequate contraceptive methods throughout the study and for 30 days after its completion, with a negative urine pregnancy test result for women of childbearing potential.\n\nNon-Inclusion Criteria:\n\n1. Clinically significant allergic history;\n2. Hypersensitivity to active and\u002For excipient substances in the investigational drug and comparator drug in the medical history;\n3. Drug intolerance to active and\u002For excipient substances in the investigational drug and comparator drug in the medical history;\n4. Chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, and immune systems, as well as skin, hematopoietic organs, and the eye;\n5. Erosive-ulcerative lesions of the oral mucosa (aphthous stomatitis, mechanical trauma due to dental diseases, herpes lesions, and any other condition resulting in compromised integrity of the oral mucosa);\n6. Surgical interventions on the GIT in the medical history (except for appendectomy performed at least 1 year prior to screening);\n7. Diseases\u002Fconditions that, in the investigator's judgment, may affect the absorption, distribution, metabolism, or excretion of the investigational drugs;\n8. Acute infectious diseases less than 4 weeks before screening;\n9. Use of medications (drugs) that significantly affect hemodynamics and drugs affecting liver function (barbiturates, omeprazole, cimetidine, etc.) less than 2 months before screening;\n10. Regular use of medications less than 2 weeks before screening and single use of medications less than 7 days before screening (including over-the-counter medications, vitamins, dietary supplements, herbal medicines);\n11. Blood or plasma donating within 3 months prior to screening;\n12. Use of hormonal contraceptives (in women) within 2 months prior to screening;\n13. Use of depot injections of any medications within 3 months prior to screening;\n14. Pregnancy or lactation; positive urine pregnancy test result for women of childbearing potential;\n15. Female subjects of childbearing potential who had unprotected sexual intercourse with an unsterilized male partner within 30 days prior to administration investigational drugs;\n16. Participation in another clinical study within 3 months prior to screening or concurrently with this study;\n17. Consumption of more than 10 alcohol units per week (1 unit of alcohol is equivalent to 500 ml of beer, 200 ml of wine, or 50 ml of strong alcoholic beverages) in the last month before inclusion in the study or a history of alcoholism, drug addiction, or substance abuse;\n18. Smoking more than 10 cigarettes per day currently or smoking that amount in the past 6 months prior to screening; unwillingness to refrain from smoking during hospitalization;\n19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to taking investigational drugs;\n20. Consumption of citrus fruits, cranberries, rose hips and products containing them, or preparations\u002Fproducts containing St. John's wort within 7 days prior to taking investigational drugs;\n21. Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours prior to taking investigational drugs;\n22. Positive blood test for antibodies to human immunodeficiency virus (HIV) types 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus antigens during screening;\n23. Positive rapid test for SARS-CoV-2 at screening;\n24. ECG abnormalities in medical history and\u002For during screening;\n25. Positive urine test for narcotic substances and potent medications during screening;\n26. Positive breath alcohol test result during screening;\n27. Planning hospitalization during the study period for any reason other than hospitalization specified in this protocol;\n28. Inability or unwillingness to comply with protocol requirements, perform procedures prescribed by the protocol, or adhere to dietary and activity restrictions;\n29. Membership in a vulnerable population? including but not limited to students of medical, pharmaceutical and dental educational institutions, junior staff of clinics and laboratories, employees of pharmaceutical companies, military personnel, prisoners, residents of care facillities, individuals with low income or unemployed, members of ethnic minorities, homeless persons, vagrants, refugees, individuals under guardianship or conservatorship, ndividuals unable to provide informed consent and law enforcement personnel;\n30. Dental procedures performed within 3 weeks prior to screening;\n31. Other conditions that in the judgment of the Investigator may prevent volunteer inclusion in the study or lead to premature withdrawal from the study including adherence to fasting or special diets (e.g., vegetarianism, veganism, salt restriction) or special lifestyles (night work, extreme physical exertion).\n\nExclusion Criteria:\n\n1. Withdrawal of the volunteer from further participation in the study;\n2. Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);\n3. Emergence of reasons\u002Fsituations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.);\n4. Volunteers selected for participation in the study who do not meet inclusion\u002Fexclusion criteria;\n5. Development of a severe adverse event (SAE) in the volunteer during the study;\n6. The volunteer undergoes or requires treatment that may affect the pharmacokinetic parameters (PKP) of the investigational drugs;\n7. Missed collection of 2 or more consecutive blood samples or 3 or more blood samples within one study period;\n8. Occurrence of vomiting\u002Fdiarrhea within 6 hours after taking the investigational drug;\n9. Positive urine test for narcotic substances and potent medications;\n10. Positive breath test for alcohol vapors;\n11. Positive pregnancy test result in women;\n12. Positive SARS-CoV-2 test result;\n13. Emergence of other reasons during the study that prevent conducting the study according to the protocol.",{"count":180,"type":22},24,[25],"This study aims to evaluate the safety, tolerability, and pharmacokinetic profile of the Grammidin, a metered dose topical spray, compared to Grammidin lozenges following single administration in healthy volunteers .",[161],{"date":166,"type":34},{"date":186,"type":34},"2024-12-10",{"date":188,"type":22},"2026-12-01",{"name":40,"class":41},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":204,"locationsCount":42},"100582021","phase-1-safety-tolerability-and-pharmacokinetic-profile-of-grammidin-with-anesthetic-a-metered-dose-topical-spray-in-healthy-volunteers-100582021","NCT06857890","Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, a Metered Dose Topical Spray in Healthy Volunteers","An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of the Drug Grammidin With Anesthetic, a Metered Dose Topical Spray Following Single Administration in Healthy Volunteers",{"count":180,"type":22},[25],"This study aims to evaluate the safety, tolerability, and pharmacokinetic profile of the Grammidin with anesthetic, a metered dose topical spray, compared to Grammidin with anesthetic neo, lozenges following single administration in healthy volunteers.",[161],{"date":166,"type":34},{"date":202,"type":34},"2024-12-09",{"date":188,"type":22},{"name":40,"class":41},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":42},"100582132","phase-1-study-of-the-safety-tolerability-and-pharmacokinetic-profile-of-ascending-doses-of-ingavirin-forte-capsules-folliwing-single-and-subsequent-multiple-oral-administration-in-healthy-volunteers-100582132","NCT06859333","Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers","An Open-label Study of the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of Ingavirin Forte, Capsules, Folliwing Single and Subsequent Multiple Oral Administration in Healthy Volunteers","Inclusion Criteria:\n\n1. Signed informed consent form by the healthy subject prior to any study activities.\n2. Males and females aged 18 to 45 years (inclusive) of Caucasian race.\n3. Verified \"healthy\" diagnosis (no abnormalities detected based on clinical, laboratory, and instrumental examination methods specified in the protocol).\n4. Blood pressure (BP) levels: systolic blood pressure (SBP) from 100 to 130 mm Hg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mm Hg (inclusive).\n5. Heart rate (HR) from 60 to 89 beats per minute (inclusive).\n6. Respiratory rate (RR) from 12 to 20 breaths per minute (inclusive).\n7. Body temperature from 36.0°C to 36.9°C (inclusive).\n8. Body mass index (BMI): 18.5 kg\u002Fm² ≤ BMI ≤ 30 kg\u002Fm², with a minimum body weight of ≥ 55 kg for men and ≥ 45 kg for women.\n9. Agreement to use adequate contraceptive methods throughout the study and for 30 days after its completion; for women of childbearing potential - a negative urine pregnancy test result.\n\nNon-inclusion criteria:\n\n1. Known allergic history.\n2. Hypersensitivity to imidazolylethylamide of pentanedioic acid and N,N'-bis-\\[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl\\] diamide of malonic acid (XC9) and\u002For excipients included in the study drug in the medical history.\n3. Drug intolerance to imidazolylethylamide of pentanedioic acid and N,N'-bis-\\[2-(1,3-diazocyclopent-2,4-dien-4-yl)ethyl\\] diamide of malonic acid (XC9) and\u002For excipients included in the study drug.\n4. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.\n5. Evidence or history of chronic diseases of the kidneys, liver, gastrointestinal tract (GIT), cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, urogenital, and immune systems, as well as skin, hematopoietic and vision organs.\n6. History of GIT surgery (except for appendectomy at least 1 year prior to screening).\n7. Diseases\u002Fconditions that, in the judgment of the investigator, may affect the absorption, distribution, metabolism, or excretion of the study drug (SD).\n8. Acute infectious diseases less than 4 weeks before screening.\n9. Use of drugs that significantly affect hemodynamics, drugs affecting liver function (barbiturates, omeprazole, cimetidine, etc.), drugs that prolong the QT interval (antipsychotics (haloperidol, quetiapine, olanzapine, risperidone, sulpiride), antidepressants (fluoxetine, sertraline), antiarrhythmics (amiodarone), antibiotics (clarithromycin, azithromycin, moxifloxacin, levofloxacin, ciprofloxacin), antifungals (fluconazole), diuretics (furosemide)), less than 2 months before screening.\n10. Regular use of drugs less than 2 weeks before screening and single use of drugs less than 7 days before screening (including over-the-counter drugs, vitamins, dietary supplements, herbal medicines).\n11. Blood or plasma donation within 3 months before screening.\n12. Use of hormonal contraceptives (in women) within 2 months before the start of screening.\n13. Use of depot injections of any drugs less than 3 months before the start of screening.\n14. Pregnancy or lactation; positive urine pregnancy test for women of childbearing potential.\n15. Women of childbearing potential who have had unprotected sexual intercourse within 30 days prior to taking study medications with an unsterilized partner.\n16. Participation in another clinical trial less than 3 months prior to screening or concurrently with this study.\n17. Consumption of more than 10 units of alcohol per week in the last month before inclusion in the study or a history of alcoholism, drug addiction, or substance abuse.\n18. Smoking more than 10 cigarettes per day currently or having smoked that amount in the past 6 months prior to screening; unwillingness to refrain from smoking during their stay at the research center.\n19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to taking the study drug.\n20. Consumption of citrus fruits, cranberries, rose hips and products containing them, preparations or products containing St. John's wort within 7 days prior to taking the study drug.\n21. Dehydration due to diarrhea, vomiting or other causes within the last 24 hours before taking the study drug.\n22. Positive blood test to human immunodeficiency virus (HIV) types 1 and 2; antibodies to Treponema pallidum antigens; surface antigen of hepatitis B virus (HBsAg); antibodies to hepatitis C virus antigens at screening.\n23. Clinically significant deviations on electrocardiogram (ECG) in medical history and\u002For at screening including: QTcF interval (corrected by Fredericia) ≥430 ms in men and ≥450 ms in women.\n24. Information on risk factors for developing torsades de pointes such as heart failure, hypokalemia, family history of prolonged QT syndrome.\n25. Positive urine test for narcotic substances and potent medications at screening.\n26. Positive test for alcohol vapors at screening.\n27. Planning hospitalization during the study period for any reason other than hospitalization provided for by this protocol.\n28. Inability or unwillingness to comply with protocol requirements, perform procedures prescribed by the protocol, adhere to dietary and activity regimens.\n29. Belonging to a vulnerable group of volunteers: students from higher and secondary medical, pharmaceutical and dental educational institutions; junior staff from clinics and laboratories; employees of pharmaceutical companies; military personnel and prisoners; individuals in nursing homes; low-income and unemployed individuals; representatives of national minorities; homeless individuals; refugees; individuals under guardianship or custody; individuals unable to give consent; as well as law enforcement officers.\n30. Other conditions that, in the judgment of the investigator, may interfere with participation in the study or may lead to early withdrawal of the volunteer including adherence to fasting or special diets (e.g., vegetarianism, veganism, salt restriction) or a special lifestyle (night work hours, extreme physical exertion).\n\nExclusion Criteria:\n\n1. The volunteer's withdrawal from further participation in the study.\n2. Non-compliance by the volunteer with the study participation rules (missed study procedures, self-administration of prohibited medications, violation of dietary and lifestyle restrictions, etc.).\n3. The emergence of reasons\u002Fsituations during the study that threaten the safety of the volunteer (e.g., hypersensitivity reactions, etc.).\n4. Volunteers selected for participation in the study who do not meet inclusion\u002Fexclusion criteria.\n5. Development of a severe adverse event (SAE) and\u002For serious adverse reaction (SAR) in the volunteer during the study.\n6. The volunteer requires or undergoes treatment that may affect the pharmacokinetics of the study drug.\n7. Missing two or more consecutive blood samples or three or more blood samples during one study period.\n8. The occurrence of vomiting\u002Fdiarrhea within 8 hours after taking the study drug.\n9. Positive urine test for narcotic substances and potent medications.\n10. Positive test for alcohol vapors.\n11. Positive pregnancy test in female participants.\n12. The emergence of other reasons during the study that prevent the conduct of the study according to the protocol.",{"count":21,"type":22},[25],"This is a Single Center, First-in-human Study of Safety, Tolerability, and Pharmacokinetic Profile of Ascending Single and Multiple Doses of Ingavirin Forte, Capsules in Healthy Volunteers.",[28,216],"Viral Respiratory Infection","2025-07-02",{"date":219,"type":34},"2025-07-08",{"date":221,"type":34},"2025-01-13",{"date":223,"type":22},"2025-12-31",{"name":40,"class":41},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":243,"leadSponsor":244,"locationsCount":245},"100580879","phase-4-efficacy-and-safety-of-ranquilon-in-patients-with-anxiety-disorders-due-to-neurasthenia-and-adjustment-disorders-100580879","NCT06843044","Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders","An Open-label, Comparative, Randomized, Multicenter Phase IV Clinical Study to Evaluate the Clinical Efficacy and Safety of the Drug Ranquilon, Tablets, 1 mg, in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders","Inclusion Criteria:\n\n1. Males and females aged 18 to 70 years;\n2. Written informed consent form in accordance with current legislation;\n3. Patients with anxiety and established diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2);\n4. Anxiety severity on the HARS scale of 18-24 points;\n5. Assessment of the severity of suicidal thoughts using the Columbia scale \\\u003C3 points;\n6. Severity of asthenia on the Multidimensional Fatigue Inventory Scale (MFI-20) greater than 50 points;\n7. Total score on the Hamilton Depression Rating Scale (HAMD-17) \\\u003C 6;\n8. Score on the CGI-s scale of at least 4 points;\n9. Negative pregnancy test for women of childbearing potential;\n10. Agreement to use effective contraceptive methods throughout the study and for 30 days after its completion (for women of childbearing potential and men);\n11. Ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of health-related information), and comply with the procedures outlined in the study protocol.\n\nNon-inclusion Criteria:\n\n1. Known intolerance to the active and\u002For excipient substances contained in the study drugs;\n2. Known lactase deficiency, lactose intolerance, glucose-galactose malabsorption, or galactose intolerance;\n3. Patients requiring prohibited concomitant therapy within this study (MAO inhibitors, antidepressants, neuroleptics, anxiolytics and sedatives (including herbal), hypnotics when used on a regular basis), or who have taken these medications within the last month;\n4. Established or suspected alcohol\u002Fnarcotic substance use at the time of screening or randomization, and\u002For a history of alcohol, narcotic, or drug dependence;\n5. Presence of oncological diseases, including in history (except for cured tumors with stable remission for more than 5 years);\n6. Tuberculosis, including in history;\n7. Presence of HIV, chronic viral hepatitis B\u002FC, syphilis (including past history), or a positive test for HIV, hepatitis B\u002FC, or syphilis at screening;\n8. Patients with a diagnosis of other anxiety disorders (F41) established based on ICD-10 criteria;\n9. Schizophrenia, schizoaffective disorders, affective disorders, and panic disorders;\n10. Acute psychosis (endogenous-processual, organic, or somatogenic), including in history;\n11. Organic lesions of the central nervous system of traumatic and alcoholic origin;\n12. Post-encephalitic syndrome;\n13. History of brain tumors (including past diagnoses);\n14. Degenerative diseases of the central nervous system (CNS), particularly multiple sclerosis;\n15. History of depression (including past episodes);\n16. Suicide attempts in history;\n17. Generalized anxiety disorder, including in history;\n18. History of epilepsy and seizures (including past episodes);\n19. Decompensated diabetes mellitus;\n20. Established diagnosis of chronic kidney disease stage 3A and above, or estimated glomerular filtration rate (eGFR) calculated by the Cockcroft-Gault formula ≤ 59 ml\u002Fmin\u002F1.73 m²;\n21. Established diagnosis of liver failure of any severity, or elevated levels of ALT, AST or total bilirubin \\>3 times the upper limit of normal according to laboratory standards;\n22. History of major surgical interventions within six months prior to screening;\n23. Chronic heart failure III-IV functional class according to the New York Heart Association (NYHA) classification;\n24. Severe, decompensated, or unstable diseases (any diseases or conditions that poses a life-threatening risk to the patient, worsens the patient's prognosis, or makes participation in the clinical study impossible);\n25. Pregnant women, breastfeeding women, or women planning to become pregnant during the study or within 30 days after participation ends;\n26. Refusal by the patient to use permitted methods of contraception or to completely abstain from sexual contact throughout the entire period of participation in the study starting from Visit 0 and for 30 days after completion of participation;\n27. Current participation or planned participation by the patient in psychological or psychotherapeutic activities aimed at treating anxiety disorder during the clinical trial period;\n28. Participation in any other clinical trial within 90 days prior to the start of the screening period;\n29. Lack of patient cooperation;\n30. Other reasons, at the investigator's discretion, that may hinder the patient's participation in the study or pose unjustified risk to the patient.\n\nExclusion Criteria:\n\n1. The patient's decision to withdraw from the study (revocation of informed consent);\n2. Each patient has the right to discontinue participation in the study at any time without explanation. Withdrawal from the study will not affect the medical care provided to the patient in the future;\n3. The investigator's decision that the patient needs to be excluded in the best interest of the patient;\n4. The patient refuses to cooperate with the investigator or is non-compliant;\n5. Emergence of reasons\u002Fsituations during the study that threaten the patient's safety (e.g., hypersensitivity reactions, serious adverse events, etc.);\n6. Inclusion of a patient in the study that does not meet the inclusion\u002Fexclusion criteria, including cases of deviation from normal values in laboratory test results obtained at Visit 0;\n7. Significant violation of the treatment regimen.\n\n   A significant violation is considered:\n   1. Missing doses of the study drugs for 2 consecutive days or more, or\n   2. Taking a total number of tablets \\\u003C 80% or \\> 120% of the full course (the full course for Ranquilon is 168 tablets, and for Afobazole, it is 84 tablets).\n8. Positive pregnancy test;\n9. Confirmed diagnosis of COVID-19;\n10. Emergence of other reasons during the study that prevent its conduct according to the protocol;\n11. Patient death;\n12. Sponsor-initiated study termination;\n13. Termination of the study by the Investigator;\n14. Termination of the study by regulatory authorities.",{"count":233,"type":22},250,[235],"PHASE4","Study is to evaluate the efficacy and safety of the drug Ranquilon, 1 mg tablets, at a dosage of 6 mg\u002Fday compared to the drug Afobazole, 10 mg tablets, at a dosage of 30 mg\u002Fday for the treatment of patients with anxiety disorders due to neurasthenia and adjustment disorders.",[238,239,240],"Anxiety","Neurasthenia","Adjustment Disorders",{"date":219,"type":34},{"date":221,"type":34},{"date":38,"type":22},{"name":40,"class":41},6,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":266,"locationsCount":267},"100540784","phase-4-efficacy-and-safety-of-vespireit-prolonged-release-tablets-in-patients-with-autonomic-dysfunction-syndrome-accompanied-by-functional-vertigo-100540784","NCT06321341","Efficacy and Safety of Vespireit, Prolonged-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo","Open-label, Multicenter, Randomized Controlled Phase 4 Trial Evaluating the Efficacy and Safety of Vespireit, Prolonged-release Tablets (Valenta Pharm JSC, Russia) Versus Arlevert, Tablets (Menarini International Operations Luxembourg S.A., Luxembourg) in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo.","Inclusion Criteria:\n\n1. Patient signed and dated the Informed Consent Form.\n2. Males and females ≥18 to ≤ 65 years of age inclusive at the time of signing the Informed Consent Form.\n3. Clinical diagnosis: G90.8 Other disorders of autonomic nervous system or G90.9 Disorder of autonomic nervous system, unspecified.\n4. Diagnosed chronic functional vertigo per Barani Society criteria: total DHI score ≥ 31 points; mean MVS score ≥ 1.5 points.\n5. For women of childbearing potential, a negative pregnancy test and consent to use an authorized method of contraception throughout the entire period of study participation, starting from Visit 0, and for 3 weeks after the end of the study; for men, consent to use an authorized method of contraception throughout the entire period of study participation and for 3 weeks after the end of the study.\n\nThe authorized contraceptive methods in this study are: intrauterine device, barrier method, or dual barrier method (condom or occlusive cap (diaphragm or cervical\u002Fvaginal cap) plus spermicide)). Hormonal contraception was not permitted due to insufficient data on drug interactions of buspirone.\n\nPostmenopausal women (≥2 years of amenorrhea) or women who are surgically sterile (hysterectomy, bilateral ovariectomy, tubal ligation)) and men with documented infertility or vasectomy will also be eligible for the study.\n\nNon-inclusion Criteria:\n\n1. Known or suspected hypersensitivity to the active substance or any of the excipients of the investigational drugs.\n2. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.\n3. A cumulative score \\> 2 on the Suicide Risk Assessment Scale (SRAS).\n4. Chronic heart failure III-IV functional classes according to the New York Heart Association (NYHA) classification, angina pectoris III-IV functional classes.\n5. Presence of uncompensated peripheral vestibular hyporeflexia due to previous vestibular neuronitis, labyrinthitis, labyrinth trauma.\n6. Presence at the time of screening of exacerbation of vestibular diseases with episodic vestibular syndrome.\n7. Meniere's disease.\n8. Established diagnosis of bilateral vestibular insufficiency.\n9. Syncopal and presyncopal conditions at the time of screening.\n10. Acute cardiovascular disease or surgical interventions (myocardial infarction, angioplasty, aortocoronary\u002Fmammary coronary heart bypass, unstable angina, and others) less than 6 months prior to the date of the Screening Visit.\n11. Acute cerebral circulatory disorders and\u002For transient ischemic attacks less than 6 months prior to the date of the Screening Visit.\n12. Hemodynamically significant cardiac rhythm and conduction abnormalities, including a history of cardiac rhythm and conduction abnormalities.\n13. An installed artificial pacemaker.\n14. Clinically significant ECG abnormalities;\n15. Established diagnosis of liver failure, including history and\u002For altered laboratory values: increase in aspartateaminotransferase (AST), alanineaminotransferase (ALT) more than 2.5 times relative to the upper limit of normal, increase in total bilirubin more than 1.5 times above the upper limit of normal;\n16. Established diagnosis of renal failure of any severity and\u002For creatinine clearance calculated by the Cockcroft-Gault formula at screening \\\u003C 80 ml\u002Fmin in women and \\\u003C 90 ml\u002Fmin in men.\n17. Pyloroduodenal obstruction based on history.\n18. Prostatic hyperplasia.\n19. Thyroid function disorder according to examination and clinical and laboratory tests.\n20. Parkinson's disease according to anamnesis.\n21. Severe ischemic heart disease.\n22. Uncontrolled hypertension with systolic blood pressure \\> 180 mm Hg and\u002For diastolic blood pressure \\> 110 mm Hg, or blood pressure (BP) at screening ≥140\u002F90 or ≤ 100\u002F60 mm Hg.\n23. Uncontrolled diabetes mellitus, diabetes mellitus in decompensation.\n24. Myasthenia gravis.\n25. Closed-angle glaucoma.\n26. Suspicion of elevated intraocular pressure at the time of screening.\n27. Systemic connective tissue diseases.\n28. Autoimmune diseases.\n29. History or suspected elevated intracranial pressure.\n30. Urinary retention due to a history of urethral and\u002For prostate disease.\n31. Need for surgical and\u002For endovascular treatment in the next 15 months.\n32. Epilepsy or convulsive seizures, including history of seizures.\n33. Alcoholism, drug dependence, substance abuse in the history and\u002For at the time of screening (alcoholism - use of more than 30 ml of ethyl alcohol per day during the last 6 months; drug dependence - use of any narcotic substances in any doses during the last 6 months; substance abuse - use of any psychoactive substances in any doses during the last 6 months).\n34. History of schizophrenia, schizoaffective disorder, bipolar disorder.\n35. Tuberculosis, hepatitis B and C, HIV infection, syphilis, history or by screening.\n36. Conditions after surgical procedures, if less than 6 months have passed since the intervention.\n37. Therapy for cognitive impairment, balance disorders, and dizziness 21 days or less prior to Visit 1-1 date.\n38. Use of an irreversible MAO inhibitor within 14 days or a reversible MAO inhibitor within 1 day prior to Visit 1-1.\n39. Therapy with the following drugs and drug groups: 7 days or less before screening: Selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SSRIs); Cinnarizine and\u002For dimenhydrinate preparations; Cytochrome P450 3A4 (Cytochrome P450 3A4, CYP3A4) inhibitors and inducers: Erythromycin, itraconazole, nefazodone, diltiazem, verapamil, etc.; Cimetidine, warfarin, phenytoin, propranolol. Monoamine oxidase inhibitors (MAOIs): concomitant use of MAO inhibitors is prohibited, as well as taking the drug earlier than 14 days after withdrawal of an irreversible MAO inhibitor, or less than 1 day after withdrawal of a reversible MAO inhibitor.\n40. Presence of a history of malignant neoplasm, except in patients who have had no disease in the past 5 years, patients with completely cured basal cell skin cancer, or completely cured carcinoma in situ.\n41. Decompensated somatic diseases that, in the opinion of the investigator, would prevent the patient from complying with the regimen prescribed by the study protocol, or would prevent assessment of the efficacy of therapy and compliance according to the protocol, or could skew the results of the study.\n42. Decompensated neuropsychiatric diseases, including multiple sclerosis, Parkinson's disease, endogenous depression, and others, which in the opinion of the investigator would prevent the patient from complying with the regimen prescribed by the study protocol, or would prevent assessment of therapy efficacy and compliance according to the protocol, or could skew the results of the study.\n43. Female patients who are pregnant or breastfeeding or planning pregnancy within the next 15 months.\n44. Patients requiring prohibited concomitant medications.\n45. Participation in another clinical trial within the last 3 months prior to the date of the Screening Visit.\n46. Patient's unwillingness or inability to comply with protocol procedures (in the opinion of the investigator).\n47. Other conditions that, in the judgment of the investigator, preclude the patient's inclusion in the study.\n48. The patient is diagnosed with COVID-19 disease at the time of screening or Randomization Visit; or the presence of symptoms of acute respiratory infections or COVID-19 within 14 days prior to screening and a positive rapid test for COVID-19 at screening.\n\nExclusion criteria:\n\n1. The patient's decision to discontinue participation in the study.\n2. A decision by the investigator that continued participation in the study is contrary to the patient's best interests.\n3. The patient is included in the study in violation of the inclusion and non-inclusion criteria.\n4. A decision by the investigator's physician to exclude the patient from the study due to lack of adequate cooperation of the patient with the investigator's physician during the study.\n5. Diagnosis of acute (vestibular neuronitis, acute labyrinthitis, traumatic vestibulopathy, stroke with lesions of central and peripheral vestibular structures and others) and\u002For episodic vestibular syndromes (benign positional paroxysmal vertigo, Meniere's disease, vestibular migraine and others), bilateral vestibulopathy.\n6. Skipping taking the study drug (3 consecutive tablets or more than 6 tablets for each period of therapy).\n7. Omission of the active comparator (9 consecutive tablets or more than 17 tablets per therapy period).\n8. An adverse event requiring withdrawal of investigational therapy or limiting protocol procedures.\n9. The need to prescribe to the patient drugs from the \"Prohibited Concomitant Therapies\" section.\n10. Loss of communication with the patient.\n11. Pregnancy.\n12. Ineffectiveness of therapy (increase from baseline or no decrease in DHI total score and MVS mean score by 25% or more from baseline after another course of therapy).\n13. The patient was diagnosed with COVID-19 disease during the periods of primary and repeated therapy.",{"count":254,"type":22},160,[235],"This study aims to evaluate the efficacy and safety of Vespireit, prolonged-release tablets, 15 mg (Valenta Pharm JSC, Russia) in comparison with Arlevert, tablets, 40 mg + 20 mg (Menarini International Operations Luxembourg S.A., Luxembourg) in patients with autonomic dysfunction syndrome accompanied by functional vertigo.",[258,259],"Vertigo","Autonomic Dysfunction","2025-06-11",{"date":262,"type":34},"2025-06-15",{"date":264,"type":34},"2024-01-24",{"date":128,"type":22},{"name":40,"class":41},4,{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},"100523672","comparative-pharmacodynamics-and-pharmacodynamics-equivalence-of-antareit-800-mg10-ml-oral-suspension-and-riopan-800-mg-chewable-tablets-in-healthy-volunteers-100523672","NCT06098742","Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg\u002F10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers","An Open-label, Randomized, Crossover Study to Investigate the Comparative Pharmacodynamics and Pharmacodynamics Equivalence of Antareit 800 mg\u002F10 ml Oral Suspension and Riopan 800 mg Chewable Tablets in Healthy Volunteers.","Inclusion Criteria:\n\n1. Voluntary and handwritten informed consent form signed by a healthy volunteer to participate in the study prior to any of the study procedures;\n2. Healthy male and female caucasian volunteers aged 18 to 45 years (inclusive);\n3. Verified diagnosis \"healthy\" (without abnormal findings in the protocol-defined clinical, laboratory, and instrumental test data);\n4. pH according to hourly pH-metry in the screening period, carried out at least 3 hours after the last meal, is completely in the range from 1 to 3 inclusive throughout the entire astronomical hour of measurement;\n5. Blood pressure (BP) levels: 100 to 139 mm Hg, inclusive (systolic, SBP), 60 to 89 mm Hg, inclusive (diastolic, DBP);\n6. Heart rate (HR) of 60 to 90 bpm, inclusive;\n7. Body mass index (BMI) of 18.5 kg\u002Fm2 ≤ BMI ≤ 30 kg\u002Fm2, where the body weight range is ≥ 55 kg for men and ≥ 45 kg for women;\n8. Non-smoking healthy volunteers (who have never smoked or gave up smoking more than 6 months prior to the Screening);\n9. Consent to use adequate methods of contraception throughout the study and for 30 days after completion; for women of preserved reproductive potential, a negative urine pregnancy test result;\n10. The volunteers must have adequate behavior and coherent speech.\n\nExclusion Criteria:\n\n1. A history of allergy;\n2. History of drug intolerance to the active and\u002For excipients included in the study drugs;\n3. History of drug intolerance of or hypersensitivity\u002Fallergic reactions to lidocaine, xylocaine or other topical anesthetics which will be used at the trial site for anesthesia during esophagogastroduodenoscopy (EGD) and insertion of the probe for the pH measurements;\n4. Chronic diseases of the circulatory, lymphatic, respiratory, nervous, endocrine, gastrointestinal, musculoskeletal, integumentary, immune, urogenital, and hematopoietic systems;\n5. Esophageal, gastric, and\u002For duodenal diseases based on EGC performed at screening and based on the medical history; a history of esophageal, gastric, and\u002For duodenal surgery;\n6. Diseases\u002Fconditions which, in the opinion of the investigator, may affect the pH measurement results;\n7. Acute infectious diseases less than 4 weeks prior to screening;\n8. Use of antacids (including sodium bicarbonate solution)\u002FH2 antagonists 24 h prior to the Screening Visit;\n9. Use of proton pump inhibitors 72 h prior to the Screening Visit;\n10. Use of (including use of a single dose) steroids and\u002For other ulcerogenic drug (e.g., nonsteriodal anti-inflammatory drugs \\[NSAID\\]) less than 4 weeks prior to the Screening Visit;\n11. Regular use of any medicinal products, including prescription only and OTC (Over-the-counter) drugs and dietary supplements within 2 weeks prior to the Screening Visit;\n12. Blood or plasma donation less than 3 months prior to the Screening Visit;\n13. Use of hormonal contraceptives (in women) less than 2 months prior to the Screening Visit;\n14. Pregnancy or breastfeeding; a positive pregnancy test for women of childbearing potential;\n15. Participation in another clinical trial less than 3 months prior to screening or simultaneously with this study;\n16. Use of more than 10 units of alcohol (1 unit of alcohol is equivalent to 330 ml of beer, 150 ml of wine or 40 ml of spirits) a week within a month prior to the enrollment in the study or history data of alcohol\u002Fdrug dependence or drug abuse.\n17. Positive antibody blood test for HIV-1 and HIV-2, Treponema pallidum antigen, hepatitis B surface antigen (HBsAg), or hepatitis C virus antigen;\n18. Positive urine test for narcotic substances or strong drugs;\n19. Positive test for alcohol vapor in exhaled breath or a positive alcohol saliva test;\n20. Deviated septum\u002Fnasal obstruction preventing the placement of the pH probe;\n21. Medical history of chronic constipation;\n22. Medical history of severe maxillofacial injuries;\n23. Expected admission to hospital during this study for any reason, except for hospitalization provided for by this protocol;\n24. Impossibility or failure to comply with the protocol, undergo protocol-defined procedures, or adhere to the diet or activity regime;\n25. Positive SARS-CoV-2 (severe acute respiratory syndrome related coronavirus) (COVID-19) rapid test;\n26. Other circumstances which in the opinion of the investigator prevent a volunteer from being included in the study or may result in premature drop-out from the study.\n\nWithdrawal criteria:\n\n1. The volunteer's refusal to further participate in the study;\n2. Failure of the volunteer to comply with the rules of participation in the study (skipping study procedures, independent use of drugs prohibited in the study, violation of dietary and lifestyle restrictions, etc.);\n3. Taking prohibited therapy;\n4. Occurrence of causes\u002Foccurrence during the study of situations that threaten the safety of the volunteer, including severe AEs;\n5. Volunteers selected to participate in the study in violation of the inclusion\u002Fnon-inclusion criteria;\n6. Violation of the rules for conducting pH measurements or the occurrence of conditions that required early termination of pH measurements (vomiting, nosebleeds, etc.);\n7. Missing a dose of the study drug\u002Fcomparator drug during any period of the study for any reason;\n8. Positive urine test for narcotics and powerful drugs;\n9. Positive breath alcohol vapor test or alcohol in saliva;\n10. Positive pregnancy test in women;\n11. Positive test for COVID-19;\n12. The occurrence in the course of the study of other reasons that prevent the study according to the protocol.",{"count":276,"type":22},50,[278],"NA","Comparative study of the pharmacodynamic parameters and pharmacodynamic equivalence (bioequivalence) of drug Antareit 800 mg\u002F10 ml oral suspension and drug Riopan 800 mg chewable tablets in healthy volunteers.",[281,282,283],"Heartburn","Acid-dependent Diseases of the Gastrointestinal Tract","Symptomatic Treatment of Gastric and Duodenal Ulcers","2024-07-19",{"date":286,"type":34},"2024-07-22",{"date":288,"type":34},"2024-04-25",{"date":290,"type":22},"2025-09-20",{"name":40,"class":41},2,""]