[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-adult-male-and-female-volunteers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-adult-male-and-female-volunteers":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,77,103,125,150,173,201],{"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":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100613690","phase-1-safety-and-pk-study-of-bicx104-with-or-without-bupropion-compared-to-vivitrol-100613690",false,"NCT07269873","Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol","A Sequential Dose Cohort Pharmacokinetic and Safety Study of Implantable Long-Acting Naltrexone Subcutaneous Pellets With or Without Bupropion Compared to Naltrexone IM Injection (Vivitrol®) in Healthy Normal Volunteers","Inclusion Criteria:\n\n1. Willing and able to provide informed consent and to read and understand study documents in English or Spanish\n2. Female or male subjects aged 18-65 years old\n3. In good health, as determined by the study physician, based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests within normal ranges, to permit treatment.\n4. Meet subjective and objective measures of being opioid-free prior to study treatment initiation, including negative urine drug screen results at screening and enrollment.\n5. BMI of 18.5 to 30.0 kg\u002Fm2, inclusive.\n6. Must agree to comply with all study requirements and be willing to complete entire study.\n7. Persons of childbearing potential agree to use acceptable birth control methods and have periodic urine pregnancy testing done during participation in the study\n\nExclusion Criteria:\n\n1. Have a history of any psychiatric disorder OR suicidal ideation, behavior, or risk of self-harm as evidenced by endorsement of items 2, 3, 4, or 5 on the C-SSRS\n2. Have a history of angle-closure glaucoma\n3. Have a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study medical clinician\n4. Have evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc interval (\\> 450 in males or \\> 470 in females), or any other finding on the screening ECG that, in the opinion of the study medical clinician, would preclude safe participation in the study\n5. Have Stage 2 hypertension as determined by the study medical clinician (e.g., greater than or equal to 160\u002F100 in 2 out of 3 readings during screening)\n6. Have any elevated bilirubin test value, or AST, ALT or alkaline phosphatase \\> 1.5 times the upper limit of normal, per laboratory criteria\n7. Have a platelet count \\\u003C100 x 103\u002FμL; known coagulopathy, or need for anticoagulant therapy during the study\n8. Have a known allergy or sensitivity to bupropion, naltrexone, or magnesium stearate, or any topical antiseptics or local anesthetics to be used in the implant procedure.\n9. Have taken an investigational drug in another study within 30 days of study consent\n10. Have a history of any substance abuse disorder, have been prescribed and taken naltrexone or bupropion within 30 days of study consent, or have been administered Vivitrol® within 60 days of study consent\n11. Be receiving ongoing treatment with antidepressants, xanthines (i.e., theophylline and aminophylline), systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous system stimulants (e.g., Adderall, Ritalin, etc.), or any medication that, in the judgment of the study medical clinician, could interact adversely with study medications\n12. Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the study medical clinician\n13. Require treatment with opioid-containing medications (e.g., opioid analgesics) during the study period\n14. Have a surgery planned or scheduled during the study period\n15. Are currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that could prevent participation in the study or in any study activities\n16. Is prone to skin rashes, keloid scars, or irritation, or has a chronic skin condition or any other condition which might predispose them to adverse reactions to the implant procedure.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Naltrexone (NTX), an opioid receptor antagonist, has a longstanding history of safe and effective use for the treatment of addictive disorders. NTX is available in several forms, such as daily oral tablets (Revia®) and sustained release monthly injections (Vivitrol®). BioCorRx Pharmaceuticals is currently developing a subcutaneous implantable pellet drug product, BICX104, which contains NTX base anhydrous (997.5 mg) and can be administered via a minor surgical procedure. BICX104 is anticipated to provide plasma concentrations of ≥ 1 ng\u002FmL NTX for 3 months.\n\nSubjects will be enrolled in 4 sequential cohorts and followed for a total of 196 days, comprising an 84-day treatment period, an 84-day follow-up period, and a 28-day post-treatment follow-up period. While therapeutic levels of naltrexone ( ≥ 1 ng\u002FmL plasma concentration) are expected to be maintained throughout the treatment period, intermittent PK sampling will continue through Day 196, at which all subjects are expected to achieve NTX levels below the level of quantitation (BLQ). Safety parameters include assessment of adverse events, vital signs, laboratory parameters, ECG data, and the Columbia Suicide Severity Rating Scale (C-SSRS), and will continue through the final safety visit at Day 196.\n\nA total of 30 healthy normal volunteers will be enrolled sequentially in the following cohorts, listed in sequence:\n\n1. One BICX104 (1.0 g NTX) implantable pellet (n = 8)\n2. One BICX104 implantable pellet with 450 mg QD bupropion XL (n = 8)\n3. Two BICX104 implantable pellets with 450 mg QD bupropion XL (n = 8)\n4. Three consecutive Vivitrol 380 mg injections Q28 days (n = 6) Enrollment will be stratified by biological sex (50% females and 50% males in each cohort)\n\nSubjects will participate in 18 clinic visits over 31 weeks comprising the 3-week screening period, 12-week treatment period, 12-week follow-up period, and 4-week safety follow-up period.\n\nThe test products will be BICX104 implantable pellets (dosage: 1 or 2 implants q. 12 weeks), Bupropion XL (dosage: 450 mg QD)\n\nBICX104 will be supplied to the clinical research site in appropriately labeled closed containers; bupropion XL will be supplied in its standard commercial packaging configuration.\n\nThe comparator product will be Vivitrol® IM injection (380 mg NTX) (dosage: 1 injection q. 4 weeks) Vivitrol® will be supplied in its standard commercial packaging configuration.\n\nThe study assessments will be as follows:\n\nAfter all screening assessments and the 24-hour Treatment Initiation Visit, safety and PK assessments will occur on Days 3, 5, 7, 14, 21, 28, 42, 56, 70, 84, 98, 112, 126, 140, 154, and 168. Final safety assessments will occur on Day 196. The Treatment Initiation Visit will involve 1 overnight stay and include PK sampling at pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 hours post-dose, in addition to safety assessments.\n\nSafety assessments will include clinical chemistry, hematology, vital signs, physical exam, ECGs, and administration of the Columbia Suicide Severity Rating Scale (C-SSRS).",[28],"Healthy Adult Male and Female Volunteers",[30,31,32,33,34,35,36],"Safety","Pharmacokinetics (PK)","Opioid Use Disorder (OUD)","Alcohol Use Disorder (AUD)","Methamphetamine Use Disorder (MUD)","Healthy Normal Volunteers","Naltrexone","RECRUITING","2026-05-12",{"date":40,"type":41},"2026-05-13","ACTUAL",{"date":43,"type":41},"2026-03-16",{"date":45,"type":22},"2026-12-05",{"name":47,"class":48},"BioCorRx Pharmaceuticals Inc","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100627167","diaphragmatic-breathing-and-stimulation-of-the-autonomic-nervous-system-100627167","NCT07445113","Diaphragmatic Breathing and Stimulation of the Autonomic Nervous System","Influence of Diaphragmatic Breathing Through Slow, Deep Respiration on Vagal Nerve Modulation and Stimulation of the Autonomic Nervous System","Inclusion Criteria:\n\n* Healthy individuals who have not smoked during the 24 hours prior to the study.\n* Healthy individuals who have not drunk alcohol during the 24 hours prior to the study.\n* Healthy individuals who have not drunk coffee during the 24 hours prior to the study.\n\nExclusion Criteria:\n\n* Individuals with cardiovascular diseases or neurological disorders.\n* Individuals with cognitive impairment.\n* Individuals taking medications that affect autonomic nervous system function, such as: benzodiazepines, beta-blockers or beta-adrenergic agents.",{"count":58,"type":22},60,[60],"NA","Introduction:\n\nSlow, deep breathing has demonstrated beneficial effects on the autonomic nervous system, particularly by increasing parasympathetic activity through vagal nerve modulation. Previous studies suggest that this breathing pattern optimizes the sympathovagal balance, modifies physiological parameters such as heart rate, blood pressure, and oxygen saturation, and influences variables including heart rate variability (HRV) and RR intervals.\n\nObjectives:\n\nTo analyze the effects of different slow deep breathing (SDB) training modalities on vagal tone regulation. Secondary objectives include evaluating their impact on heart rate and rhythm, HRV, cardiac beat intervals, blood pressure, and oxygen saturation.\n\nMethodology:\n\nA randomized, controlled, single-blind, parallel-design clinical trial will be conducted. Sixty healthy participants will be enrolled and allocated into three groups: two experimental groups (SDB with and without apnea) and one control group (breathing education). Pre- and post-intervention measurements will include HRV, RR intervals, heart rate, blood pressure, oxygen saturation, and cervical joint variables. Data will be analyzed using repeated-measures ANOVA and statistical tests appropriate for each variable type, with a significance level set at 5%.\n\nExpected Results:\n\nSDB-based interventions are expected to produce significant improvements in vagal regulation, increasing heart rate variability and favorably modifying the aforementioned physiological parameters compared with the control group.",[28],[64,65,66],"Slow diaphragmatic breathing","autonomic nervous system","heart rate variability","NOT_YET_RECRUITING","2026-03-03",{"date":70,"type":41},"2026-03-05",{"date":72,"type":22},"2026-02-15",{"date":74,"type":22},"2026-05-31",{"name":76,"class":48},"University of Jaén",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":49},"100612251","phase-1-pharmacokinetic-comparison-of-vonafexor-acid-and-its-lysine-salt-and-evaluation-of-potential-drug-drug-interactions-100612251","NCT07251153","Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions","A Phase 1, Two Parts, Open-label, Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt (EYP651) in Healthy Volunteers and Evaluation of Potential Drug-Drug Interactions","Inclusion Criteria:\n\n* Healthy male or female subject, aged 18-65 years inclusive.\n* Females of childbearing potential: commitment to use a highly effective method of birth control which result in a low failure rate.\n\nFemales of non-childbearing potential: either at least 3 months surgically sterilized or at least 1-year postmenopausal confirmed by the follicle stimulating hormone (FSH) level.\n\nMales: commitment to use an adequate contraceptive method consistently and correctly.\n\n* Negative pregnancy test for childbearing potential women or FSH ≥ 40 IU\u002FmL for postmenopausal women.\n* Non-smoker subject or smoker of maximum 5 cigarettes a day and able to stop during the study.\n* Body Mass Index (BMI) between 18 and 30 kg\u002Fm2 inclusive.\n* Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination).\n* Normal Blood Pressure and Heart Rate.\n* Normal ECG recording on a 12-lead ECG.\n* Laboratory parameters within the normal range of the laboratory (hematology, hemostasis, blood chemistry tests, urinalysis).\n* Normal dietary habits.\n* Signing a written informed consent prior to selection.\n* Covered by Health Insurance System and \u002F or in compliance with the recommendations of National Law in force relating to biomedical research.\n\nExclusion Criteria:\n\n* Any relevant history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease.\n* Frequent headaches and \u002F or migraine, recurrent nausea and \u002F or vomiting.\n* Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension.\n* Blood donation in the 2 months before administration.\n* General anaesthesia in the 3 months before administration.\n* Presence or history of drug allergic condition and\u002For hypersensitivity.\n* Inability to abstain from intense muscular effort.\n* Any drug intake (except paracetamol and contraceptives) during the month prior to the first administration.\n* History or presence of drug or alcohol abuse (alcohol consumption \\> 40 grams \u002F day).\n* Excessive consumption of beverages with xanthine bases (\\> 4 cups or glasses \u002F day).\n* Positive Hepatitis B surface antigen or anti Hepatitis C Virus antibody, or positive results for Human Immunodeficiency Virus 1 or 2 tests.\n* Positive results for drugs of abuse tests.\n* No possibility of contact subject in case of emergency.\n* Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.\n* Exclusion period of a previous study.\n* Administrative or legal supervision.\n* Subject who would receive more than 6'000 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.",{"count":85,"type":22},40,[25],"The purpose of this study is to define and compare the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EYP651 at two dose levels and compare it with Vonafexor Acid PK and PD profile, the Part A.\n\nIn addition, Part B of the trial will assess the Drug-Drug Interactions (DDI) potential with the high dose of EYP651.",[28],[90,91,92],"Drug-Drug Interactions","Pharmacokinetic","Pharmacodynamic","2026-02-25",{"date":95,"type":41},"2026-02-27",{"date":97,"type":41},"2025-10-28",{"date":99,"type":22},"2026-10-28",{"name":101,"class":102},"Enyo Pharma","INDUSTRY",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":121,"leadSponsor":123,"locationsCount":49},"100624748","phase-1-a-study-of-orx489-in-healthy-adult-participants-aged-18-to-60-years-100624748","NCT07413666","A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years","A Safety, Tolerability, Pharmacokinetic, Food Effect, and Proof-of-Concept Study of Single and Multiple Doses of ORX489 in Healthy Adults","Inclusion Criteria:\n\n* Healthy males or females as determined by assessments at the Screening Visit.\n* For Parts A, B, C, and D: Participants must be at least 18 years of age and no more than 60 years of age at the Screening\n\nExclusion Criteria:\n\n* Presence of significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological, or psychiatric disease, as determined by medical history, physical examination, and screening investigations.\n* History of seizure disorder, any other condition that increases the risk of seizure\n* Has a clinically significant sleep disorder, including insomnia or sleep apnea","60 Years",{"count":112,"type":22},212,[25],"Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.",[28],[117],"Healthy Volunteers orexin-2 receptor agonist","2026-02-23",{"date":93,"type":41},{"date":93,"type":22},{"date":122,"type":22},"2027-06-30",{"name":124,"class":102},"Centessa Pharmaceuticals (UK) Limited",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":49},"100608440","phase-1-a-comparative-bioavailability-study-of-two-torasemide-10-mg-tablets-formulations-in-healthy-adult-participants-under-fasting-conditions-100608440","NCT07201584","A Comparative Bioavailability Study of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions:","A Comparative Bioavailability of Two Torasemide 10 mg Tablets Formulations in Healthy Adult Participants Under Fasting Conditions: a Prospective, Open-label, Randomized, Single-dose, Two-treatment, Two-period, Two-sequence, Crossover Bioequivalence Study","Inclusion Criteria:\n\n1. Healthy male and female individuals aged 18 to 55 years inclusive at the time of signing the ICF.\n2. Body weight ≥50 kg and Body Mass Index (BMI) between ≥18.5 and \\\u003C30.0 kg\u002Fm2.\n3. A healthy individual as determined by the Investigator based on medical history and results of standard clinical, laboratory and instrumental methods of examination (individuals with not clinically significant \\[NCS\\] abnormalities are eligible for the study).\n4. A non-smoker (for at least 3 months before screening), verified by the cotinine test at screening.\n5. A negative urine pregnancy test (rapid test) within 24 h before the first IMP dose for female individuals of childbearing potential. Postmenopausal (no menses for at least 1 year) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) females are exempted from the requirement.\n6. Individuals with preserved reproductive potential should agree to use, with their partner, adequate contraception throughout the study and for 30 days thereafter (contraceptive methods with reliability greater than 90%: cervical caps with spermicide, diaphragms with spermicide, condoms with intravaginal spermicide, non-hormonal intrauterine devices), or true sexual abstinence.\n7. Capable of understanding the ICF and giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and the study protocol.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or intolerance to torasemide, other sulfonylureas, or any other excipient of the IMPs.\n2. History of renal failure with anuria.\n3. History of hepatic precoma, coma.\n4. History of hypotension.\n5. History of hypovolemia.\n6. History of hyponatremia and\u002For hypokalemia.\n7. History of substantial micturition disorders (e.g. due to prostatic hypertrophy).\n8. History of gout.\n9. History of cardiac arrhythmias (e.g. SA block, 2nd or 3rd degree AV block).\n10. History of latent or manifest diabetes mellitus or any form of hyperglycemia.\n11. History of pathological changes in the acid-base balance.\n12. History of pathological changes in the blood count (e.g. thrombocytopenia, anemia in patients without renal insufficiency).\n13. History of abnormally high (≥190 mg\u002FdL \\[≥4.9 mmol\u002FL\\]) low-density lipoprotein (LDL) cholesterol levels within 3 months before the first IMP dose.\n14. Abnormally high triglycerides levels (\\>150 mg\u002FdL \\[\\>1.7 mmol\u002FL\\]) within 3 months before the first IMP dose.\n15. History of renal insufficiency (creatinine clearance between 20 mL and 30 mL\u002Fmin and\u002For serum creatinine concentrations between 3.5 mg\u002FdL and 6 mg\u002FdL) due to nephrotoxic substances.\n16. History of other clinically significant cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal, hematological, genito-urinary disease, bleeding disorders, neurological or psychiatric pathology, oncologic disease, autoimmune disease, dermatological disease or other chronic disease, that makes the individual ineligible for the study.\n17. Acute infectious diseases (e.g. influenza, acute respiratory bacterial or viral infections incl. COVID-19) less than 4 weeks before the first IMP dose.\n18. Hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.\n19. Systolic blood pressure \\\u003C 90 mmHg or ≥ 130 mmHg and\u002For diastolic blood pressure \\\u003C 60 mmHg or ≥ 85 mmHg.\n20. Heart rate \\\u003C 60 or \\> 100 beats per minute.\n21. The presence of any other condition which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.\n22. Use of the following medications within the relevant period before the first IMP dose:\n\n    1. Use of medications (including hormonal contraceptives) that have a significant effect on circulatory dynamics, liver function, etc. (barbiturates, omeprazole, cimetidine, non-steroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, diuretics, etc.) within 2 months before the first IMP dose.\n    2. Use of depot-forms of any medications within 3 months before the first IMP dose.\n    3. Use of any other prescribed or non-prescribed medication, herbal remedies, vitamins and minerals within 2 weeks before the first IMP dose or longer (at least 5 elimination half-lives) if the medication has a long half-life.\n23. Female individuals who are lactating.\n24. Female individuals of childbearing potential, having unprotected sexual intercourse with any unsterilized male partner (i.e., a man who is not sterilized by vasectomy for at least 6 months) within 30 days before the first IMP dose.\n25. Blood donation\u002Fblood loss \\>450 mL within 60 days or apheresis donation within 30 days before the first IMP dose.\n26. Dehydration (e.g. due to diarrhea, vomiting, or other causes) within the last 48 h before the first IMP dose.\n27. Positive test result for COVID-19 rapid antigen test at admission to the Study Site.\n28. Positive test results for HIV or hepatitis B (HBsAg, anti-HBc) or C (anti-HCV) or syphilis at screening.\n29. History of drug or alcohol abuse within 1 year before the screening. Alcohol abuse is defined as regular intake of more than 10 units of alcohol a week (1 unit equivalent to 200 mL of dry wine or 50 mL of strong alcoholic drinks or 500 mL of beer).\n30. Positive screen for drugs or alcohol at screening.\n31. Individuals who have been on a special diet (for whatever reason, e.g. vegetarians or hypocaloric diet \\[\\\u003C 1000 kcal\u002Fday\\]) within the 28 days before the first IMP dose and throughout the study.\n32. Intake of methylxanthine-containing substances (e.g., coffee, tea, chocolate, cocoa, energy drinks, cola) as well as citrus fruits and cranberry (including juices, fruit drinks, etc.) within the last 48 h before the first IMP dose.\n33. Intake of food or beverages containing poppy seeds within 72 h before the first IMP dose.\n34. Excessive consumption (defined as greater than 6 servings - 1 serving being approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks or other caffeinated beverages per day within 2 weeks before the first IMP dose.\n35. Mental, physical and other reasons that do not allow the individual, according to Investigator's opinion, to assess their behavior adequately, to follow correctly the requirements of the clinical study protocol and to assess the expected risks and possible discomfort.\n36. Participation in another clinical study (except if no investigational product was administered) within 3 months before the first IMP dose.\n37. Employee or family member of the Sponsor or the involved Contract Research Organization (CRO) or the Study Site.","55 Years",{"count":134,"type":22},26,[25],"The purpose of this study is to evaluate the bioavailability, safety and tolerability of Torasemide 10 mg tablets (Berlin-Chemie AG), compared to Unat® 10 tablets (Viatris Healthcare GmbH) in healthy adult participants under fasting conditions.",[28],[139,140],"Torasemide","Bioequivalence","2026-01-13",{"date":143,"type":41},"2026-01-14",{"date":145,"type":41},"2025-09-05",{"date":147,"type":22},"2026-04-01",{"name":149,"class":102},"Berlin-Chemie AG Menarini Group",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":49},"100617031","exploring-resistance-exercise-training-plus-high-intensity-interval-training-rehiit-as-cancer-prehabilitation-100617031","NCT07313332","Exploring Resistance Exercise Training Plus High-Intensity Interval Training (ReHIIT) as Cancer Prehabilitation","Exploring Resistance Exercise Training Plus High-Intensity Interval Training (ReHIIT) as Cancer Prehabilitation: A Healthy Control Group Pilot Study","ReHIIT_CON","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Availability and willingness to attend the Royal Derby Hospital site for a minimum of 8 exercise sessions and 2 assessment sessions across the study period.\n\nExclusion Criteria:\n\n* BMI \\\u003C18 or \\>35 kg\u002Fm2\n* Known active cance\n* Known metabolic disease\n* Current known neurological or musculoskeletal conditions (e.g. epilepsy)\n* Active known cardiovascular, cerebrovascular or respiratory disease - e.g:\n* Uncontrolled hypertension (systolic BP \\> 160 mmHg or diastolic BP \\>100 mmhg)\n* Myocardial infarction within the last 6 months or unstable angina\n* Heart failure (New York Heart association Class III\u002FIV)\n* Arrhythmia\n* Right to left cardiac shunt\n* Aneurysm of a named blood vessel\n* COPD\n* Pulmonary hypertension\n* Exercise-induced or brittle asthma\n* Previous stroke\u002Ftransient ischaemic attack\n* Abnormal ECG results (at the discrepancy of the study doctor)\n* Patients who are unable to undergo CPET based on ATS\u002FACSS guidelines \\^\n* Pre-existing clotting disorder known to the participant or anticoagulant use\n* Family history of severe bleeding requiring medical intervention\n* Participation in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (ALL UoN FMHS UREC approved studies)\n* Pregnant or breastfeeding",{"count":159,"type":22},14,[60],"Colorectal cancer is the fourth most common cancer in the UK. Prehabilitation, including exercise, can improve recovery from surgery. This pilot study investigates the combined effects of resistance and high-intensity interval training (ReHIIT) in healthy adults to establish baseline physiology and responses for comparison with cancer patients",[28,163],"Intervention","2025-12-16",{"date":166,"type":41},"2025-12-31",{"date":168,"type":22},"2026-01-01",{"date":170,"type":22},"2027-12-01",{"name":172,"class":48},"University of Nottingham",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":49},"100609956","evaluating-a-mat-based-biometric-vibration-system-for-sleep-and-daily-recovery-100609956","NCT07221318","Evaluating a Mat-Based Biometric Vibration System for Sleep and Daily Recovery","Evaluating the Physiological and Psychological Impact of Low-Frequency Vibration Therapy: A Longitudinal Randomized Clinical Trial","Inclusion Criteria:\n\n* Adults 18-45 years.\n* Able to provide written informed consent.\n* Apparently healthy and free of unstable cardiovascular, neurological, or psychiatric conditions per screening.\n* Cleared for low-to-moderate intensity whole-body vibration delivered supine\u002Frecumbent on a mat.\n* Willing and able to comply with study procedures: two lab visits; 3-week home protocol (3-4 days\u002Fweek); three 15-min sessions; brief affect check-ins and daily logs.\n* Willing to abstain from caffeine, alcohol, and strenuous exercise for 24 hours before each lab visit and to attend visits at the same time of day.\n* Able to lie supine for 15 minutes and follow instructions for the HRV device.\n\nExclusion Criteria:\n\n* Implanted electronic medical devices (e.g., pacemaker, neurostimulator).\n* Uncontrolled hypertension or severe vestibular disorders.\n* Current substance dependence.\n* Medications known to markedly affect autonomic function or sleep architecture (e.g., beta-blockers, antiarrhythmics, sedative-hypnotics, antidepressants with strong autonomic effects).\n* Diagnosed neurological or psychological disorders that substantially affect emotional processing or autonomic regulation (severe psychiatric conditions).\n* Prior extensive experience with vibration therapies (to minimize expectancy bias).\n* Any condition judged by study staff to contraindicate vibration exposure or preclude safe participation (including inability to tolerate supine\u002Frecumbent position).\n* Unwillingness to refrain from initiating new structured exercise or relaxation programs during the study period.","45 Years",{"count":182,"type":22},50,[60],"The goal of this randomized clinical trial is to learn whether a low-frequency \"kinetic wellness\" mat (a comfortable mat that gently vibrates) can improve stress recovery, sleep quality, mood, and attention in healthy adults ages 18-45.\n\nThe main questions it aims to answer are:\n\n* After 3 weeks, does regular use of the vibrating mat increase heart rate variability (a noninvasive marker of the body's ability to recover from stress) and improve sleep, mood, perceived stress, and anxiety compared with no mat use?\n* Do patterns of resting brain activity (measured with EEG) and heart rate variability (HRV) change from before to after the program, and are those changes related to each other?\n\nResearchers will compare two groups: an Experimental group that uses the vibrating mat at home for 3 weeks, and a Control group that does not use the mat. Participants are randomly assigned to a group.\n\nParticipants will:\n\n* Attend two lab visits (\\~60 min) for questionnaires, resting heart activity (HRV) and brain activity (EEG), and a brief attention test.\n* On 3-4 days per week for 3 weeks:\n* Experimental group: use the vibrating mat for 15 minutes while recording HRV.\n* Control group: lie quietly for 15 minutes while recording HRV.\n* Both groups: record HRV for 15 minutes before bedtime and 15 minutes after waking on those same days.\n* Both groups: complete quick check-ins on feelings (after sessions and the next morning) and log caffeine\u002Falcohol, exercise, and medications.",[28],[187,188,189,190,191],"whole-body vibration therapy","sleep quality","affect","mood","relaxation therapy","2025-10-24",{"date":194,"type":41},"2025-10-27",{"date":196,"type":41},"2025-10-06",{"date":198,"type":22},"2026-05",{"name":200,"class":48},"Florida International University",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":49},"100587999","phase-1-safety-and-pharmacokinetics-of-y-4-tablets-in-healthy-subjects-100587999","NCT06935682","Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects","A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Study to Assess the Safety and Pharmacokinetics of Y-4 Tablets After Single- and Multiple-dose in Healthy Subjects","Inclusion Criteria:\n\n1. Healthy adult male and female subjects, 18-45 years of age (including both ends).\n2. Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg\u002Fm2 (including both ends).\n3. During the screening period, serum creatinine is within the normal range, or the standard creatinine clearance (CLcr) estimated by Cockcroft-Gault formula is ≥ 80 mL\u002Fmin (for female subject, according to the calculation result × 0.85）.\n4. Subjects who are able to understand and give their signed informed consent before any trial related procedures are performed.\n\nExclusion Criteria:\n\n1. Subjects who are known to be allergic to pregabalin, riluzole or any excipients of Y-4 tablets (microcrystalline cellulose, Copovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and Opadry amb Ⅱ), have allergic diseases or allergic constitution;\n2. Subjects who have special requirements for diet and cannot follow the unified diet;\n3. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), chest X-ray (front position), laboratory tests (hematology, serum chemistry, coagulation test, urinalysis, etc.) and other screening tests found abnormalities that the researchers judged to be of clinical significance;\n4. Subjects who have experienced angioedema in the past (such as swelling of the face, mouth (tongue, lips, and gums), and neck (pharynx and throat));\n5. History of dizziness or vertigo with clinical significance, or disease of inner ear known to cause dizziness or vertigo;\n6. QTcF \\> 450 msec at the screening stage;\n7. Diagnosed with insomnia, anxiety disorder, depression, epilepsy, or other serious mental disorders, and principal investigator determines that the subject is not suitable to participate in this trial;\n8. Presence or history of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of medicines;\n9. Subjects who drink too much tea, coffee and\u002For caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months prior to screening, or disagree that any caffeine-containing beverages are prohibited during the trial;\n10. Subjects who have consume any diet (food or beverage) rich in grapefruit, pitaya, mango and cranberry within 14 days prior to screening;\n11. Subjects have disease history or current disease that may affect the safety evaluation of the subject or the internal process of the study drug, including the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, immunology, psychiatry, metabolic abnormalities, gastrointestinal surgery (excluding appendicitis surgery), etc. In particular, there is a history of dysphagia or any gastrointestinal disease affecting drug absorption (including frequent nausea or vomiting caused by any cause) and eye diseases;\n12. Donation or loss of blood equal to or in excess of 400 mL, or blood transfusion within 3 months prior to screening; or donation or loss of blood equal to or in excess of 200 mL within 1 month prior to screening;\n13. Subjects who have taken any drugs known to be strong inhibitors or inducers of cytochrome P450 enzymes within 2 months prior to screening (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - serotonin reuptake inhibitors (SSRI) antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); or subjects who have taken any prescription drugs, over-the-counter drugs and Chinese herbal medicine other than the above drugs within 14 days prior to screening;\n14. Subjects who have taken central nervous system (CNS) depressants including opioids (pethidine hydrochloride, morphine, dihydromorphine hydrochloride, fentanyl, tramadol, etc), benzodiazepines (diazepam, flurazepam, clonazepam, oxazepam, chlordiazepine and triazolam etc), antiepileptic drugs (carbamazepine, sodium valproate, phenobarbital drugs etc) within 2 months prior to screening;\n15. Subject with sleep apnea, or subjects with severe sleep snoring and daytime drowsiness;\n16. Subjects with suicidal thoughts and behavior;\n17. Subject participated in any other clinical trials within 3 months prior to screening;\n18. Current or former drug users, or positive urine screen for drugs of abuse at screening (screening items include: dimethylenedioxyamphetamine, methamphetamine, ketamine, morphine, tetrahydrocannabinoid acid, cocaine);\n19. Alcoholics or regular drinkers within 3 months prior to screening, that is, those who drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of alcohol with 40% alcohol content or 150 mL of wine), or whose alcohol breath test results are greater than 0.0 mg\u002F100 mL, or who cannot abstain from alcohol during the trial;\n20. Smokers or those who cannot comply with the prohibition of smoking during the trial, or positive for cotinine screening;\n21. Subjects who is positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody;\n22. Male subjects (or their partners) or female subjects have baby plans during the whole trial period and within 3 months after the end of the trial, or subjects are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, ligation, etc.) during the trial period;\n23. Female subjects who have unprotected intercourse within 14 days prior to screening, or pregnant or lactating women;\n24. Subjects with poor compliance or other factors unsuitable for participation in this trial.",{"count":209,"type":22},36,[25],"Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole.\n\nThe primary objective is to evaluate the safety and tolerability of Y-4 tablets in Chinese healthy adult subjects after single- and multiple-dose.\n\nThe secondary objective is to characterize the pharmacokinetics (PK) of pregabalin and riluzole in Chinese healthy adult subjects after single- and multiple-dose of Y-4 tablets.",[28],[214],"phase I trial","2025-04-13",{"date":217,"type":41},"2025-04-20",{"date":219,"type":41},"2025-01-04",{"date":221,"type":22},"2025-06-30",{"name":223,"class":48},"Beijing Tiantan Hospital"]