[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Union Pharmaceutical Factory Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,64,88],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100628096","phase-1-pharmacokinetic-study-of-buagafuran-capsules-in-participants-with-hepatic-impairment-and-normal-hepatic-function-100628096",false,"NCT07457190","Pharmacokinetic Study of Buagafuran Capsules in Participants With Hepatic Impairment and Normal Hepatic Function","Pharmacokinetic and Safety Study of Buagafuran Capsules in Participants With Hepatic Impairment and Normal Hepatic Function","Inclusion Criteria:\n\n1. Voluntarily sign an informed consent form before the start of activities related to this trial, understand the procedures and methods of this trial, and be willing to strictly follow the clinical trial protocol to complete this trial;\n2. Participants (including partners) are willing to have no fertility plans from screening to within 6 months after the last administration of the study drug, and voluntarily adopt highly effective contraceptive measures;\n3. On the day of signing the informed consent form, the age range is 18 to 70 years old (including both ends), and both males and females are eligible;\n4. Male participants should weigh no less than 50 kg, and female participants should weigh no less than 45 kg; Body Mass Index (BMI) should be between 18 and 32 kg\u002Fm2 (including both ends), with BMI=weight (kg)\u002Fheight (m2);\n5. Creatinine clearance rate ≥ 60 mL\u002Fmin;\n6. Participants with normal hepatic function must also meet all of the following criteria: a): Weight matching with the hepatic impairment group, with an average weight range of ± 10 kg; b): Age matching with the hepatic impairment group, with an average age range of ± 10 years; c): The number of participants of each gender is similar to that of the hepatic impairment group (mean ± 1 participant\u002Fgender);\n7. Participants with hepatic impairment must also meet all of the following conditions: a): Chronic hepatic impairment caused by primary hepatic diseases, and hepatic impairment patients with Child Pugh classification of A or B; b):The clinical diagnosis is cirrhosis; c): Individuals who have a stable medication regimen for treating hepatic impairment, complications, and other accompanying diseases for at least 14 days prior to taking the investigational drug, and whose medication does not require adjustment; or those who have not taken medication;\n\nExclusion Criteria:\n\n1. Allergic constitution, including individuals with a history of severe drug allergies or drug hypersensitivity reactions, known to be allergic to the study drug or any component of the study drug;\n2. During the screening period, the electrocardiogram showed a QTc interval of\\>470 milliseconds in males and\\>480 milliseconds in females;\n3. Individuals with a history of swallowing difficulties or any gastrointestinal diseases that affect drug absorption, including frequent nausea or vomiting caused by any underlying cause;\n4. Those who need treatment for bacterial, viral, parasitic or fungal infection with any clinical symptoms during screening (excluding hepatitis B and hepatitis C), and those who have a history of serious active infection within 1 month before screening;\n5. Individuals who have undergone major surgeries within the previous 6 months (defined as surgeries involving intracranial, chest, abdominal, pelvic, or limb organs that cause significant tissue trauma and require long-term recovery (such as organ transplantation, heart surgery, or joint replacement), or those who plan to undergo surgery during the study period; Individuals with a history of liver transplantation; Participants who have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion in the past (such as gastric and duodenal resection surgery) or who may be hospitalized due to surgery or other reasons during the expected trial period;\n6. Screening individuals who have received the vaccine within the previous 14 days or plan to receive the vaccine during the study period;\n7. Screening individuals who have donated blood or lost blood ≥ 200 mL within the first 3 months, or plan to donate blood during the trial period or within 1 month after the trial ends;\n8. Screening for individuals who have used other clinical trial drugs within the previous 3 months or plan to participate in other clinical trials during the study period;\n9. Within one month prior to screening (or 5 times the half-life, whichever is longer), strong or moderate inducers or inhibitors of CYP2B6, CYP3A4, renal transporter inhibitors, etc. have been used;\n10. Consuming grapefruit or products containing grapefruit, food or beverages containing caffeine, xanthine, or alcohol (including chocolate, tea, coffee, cola, etc) 48 hours prior to receiving the investigational drug; Those who engage in vigorous exercise or have other factors that affect drug absorption, distribution, metabolism, excretion, etc;\n11. Screening for alcoholics within the first 3 months, those who consume more than 14 units of alcohol per week (1 unit=360 mL of beer, 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine) or have a positive alcohol screening result; Individuals who smoke an average of 10 or more cigarettes per day within the first 3 months of screening;\n12. Individuals with a history of drug use, drug abuse, or positive drug abuse screening;\n13. Pregnant or lactating women, or women of childbearing age who test positive for pregnancy;\n14. Those who cannot tolerate venipuncture or have a history of needle and blood dizziness;\n15. Other reasons why researchers believe it is not suitable for inclusion;\n\n    Participants with normal hepatic function who meet any of the following exclusion criteria need to be excluded:\n16. History of hepatic impairment;\n17. Individuals who have previously or currently suffered from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that may interfere with the test results;\n18. Abnormal physical examination, vital signs, laboratory tests, 12 lead electrocardiogram, abdominal ultrasound and other examinations have clinical significance as determined by the researchers;\n19. Those who are positive in any index screening of hepatitis B surface antigen, hepatitis C antibody, HIV antigen\u002Fantibody or syphilis antibody;\n20. Have used any prescription drugs, over-the-counter drugs, herbal medicines, or supplements within 14 days prior to receiving the investigational drug.\n\n    Participants with hepatic impairment who meet any of the following exclusion criteria must be excluded:\n21. Participants have any of the following conditions: acute hepatic function damage caused by various reasons; History of liver transplantation; And researchers believe that patients with liver cirrhosis complicated with the following complications: including but not limited to hepatic failure, hepatic encephalopathy, hepatocellular carcinoma (excluding liver cancer patients who have received curative treatment and have not relapsed; excluding liver cancer patients with BCLC stage 0), and those who have experienced esophageal and gastric variceal bleeding within the past 3 months before screening;\n22. The laboratory test results during screening meet any of the following criteria: (a) ALT or AST\\>10 × ULN; (b) NE#\\\u003C0.75×109\u002FL；(c) HGB\\\u003C60 g\u002FL； (d) AFP\\>100 ng\u002FmL; (e) Platelet count\\\u003C40 × 109\u002FL; any remaining abnormalities that have clinical significance and have been determined by the researchers to be unsuitable for participation in this trial;\n23. Individuals who test positive for HIV antigen\u002Fantibody screening; If syphilis antibodies are positive, rapid plasma reagin (RPR) testing should be added. If RPR is also positive, it should be excluded;\n24. In addition to the primary liver disease itself, those who have previously or currently suffered from other serious organ systemic diseases, including but not limited to gastrointestinal, respiratory, renal, neurological, blood, endocrine, tumor, immune, psychiatric or cardiovascular diseases, or abnormalities with clinical significance such as physical examination and chest radiograph, and have been determined by the research doctor to be unsuitable for participation in this trial.",true,"ALL","18 Years","70 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study adopts a non-randomized, open label, parallel, single-dose design to evaluate the safety and pharmacokinetic characteristics of Buagafuran capsules in participants with hepatic impairment.",[28],"Generalized Anxiety Disorder","NOT_YET_RECRUITING","2026-03-08",{"date":32,"type":33},"2026-03-10","ACTUAL",{"date":35,"type":22},"2026-03",{"date":37,"type":22},"2026-12",{"name":39,"class":40},"Beijing Union Pharmaceutical Factory Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100628097","phase-1-study-on-the-drug-interaction-between-buagafuran-and-voriconazole-100628097","NCT07457203","Study on the Drug Interaction Between Buagafuran and Voriconazole","Clinical Study on the Drug Interaction Between Buagafuran Capsules and Voriconazole Tablets in Chinese Adult Healthy Participants","Inclusion Criteria:\n\n1. Voluntarily sign an informed consent form before the start of activities related to this experiment and be able to understand the procedures of this experiment Willing to strictly adhere to the clinical trial protocol and complete this trial in accordance with the method;\n2. Participants (including partners) are willing to have no fertility plans from screening to within 6 months after the last administration of the investigational drug, and voluntarily adopt highly effective contraceptive measures (specific contraceptive measures can be found in Appendix 1);\n3. On the day of signing the informed consent form, the age range is 18 to 45 years old (including both ends), and both males and females are eligible;\n4. Male participants weighing no less than 50 kg and female participants weighing no less than 45 kg; Body Mass Index (BMI)19-28 kg\u002Fm2 (including both ends), body mass index (BMI)=weight (kg)\u002Fheight 2 (m2);\n5. Creatinine clearance rate (calculated using the Cockcroft Gault formula, see Appendix 2) ≥ 80 mL\u002Fmin.\n\nExclusion Criteria:\n\n1. Screening period physical examination, vital sign examination, 12 lead electrocardiogram, clinical laboratory examination (blood routine Abnormal and clinically significant factors such as blood biochemistry, urine routine, coagulation function, etc. have been identified by researchers;\n2. Clinical findings indicate the presence of the following diseases: including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, and endocrine disorders Secretory, tumor, lung, immune, psychiatric or cardiovascular diseases that the researcher deems unsuitable to participate in this study Researcher;\n3. Any potential impact on the safety of the trial or drug absorption, distribution, metabolism, or excretion within the first 6 months of screening Individuals with a history of surgery or trauma, or those planning to undergo surgery during the study period;\n4. History of swallowing difficulties or any gastrointestinal diseases that affect drug absorption, including frequent malignant events caused by any underlying cause Individuals with a history of heart or vomiting;\n5. Individuals with a history of eye diseases (such as retinal hemorrhage, optic nerve abnormalities, etc.);\n6. Individuals with previous risk factors for arrhythmia, such as congenital or acquired QTc interval prolongation, cardiomyopathy, and menstrual disorders Researchers have identified clinically significant abnormalities such as sinus bradycardia;\n7. Participate in blood donation within 3 months prior to screening and donate ≥ 400 mL (excluding female menstrual bleeding), or Blood transfusion recipients;\n8. Screening for use of other clinical trial drugs within the first 3 months or planned participation in other clinical trials during the study period The person;\n9. Individuals with a history of drug abuse, drug dependence, drug use, or urinary drug abuse within the past 5 years prior to screening Individuals with positive screening results;\n10. Individuals with a history of alcohol abuse or those who have frequently consumed alcohol within the past 6 months, i.e. those who consume ≥ 14 units of alcohol per week (1 Unit=360 mL of beer with an alcohol content of 5%, 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of alcohol 12% wine), or any alcoholic product taken on the day before the first dose, or alcohol blowing Individuals who test positive for alcohol or are unable to stop consuming alcohol during the study period;\n11. Excessive smoking (≥ 5 cigarettes\u002Fday) within the first 3 months of screening, or inability to stop smoking during the trial period;\n12. Those who are positive in any index screening of hepatitis B surface antigen, hepatitis C antibody, HIV antigen\u002Fantibody or syphilis antibody;\n13. Used any drugs that affect liver enzymes within the previous month (or 5 times half-life, whichever is longer) before screening Active drugs (including inhibitors and inducers that affect metabolic enzymes);\n14. Within 14 days prior to the first use of the investigational drug, any prescription, over-the-counter, herbal, or herbal medicine has been used Health products (excluding topical preparations that exert local effects);\n15. Consuming grapefruit or products containing grapefruit, caffeine, and yellow within 48 hours prior to taking the investigational drug Foods or beverages containing purines or alcohol (including chocolate, tea, coffee, cola, etc.); Intense exercise, or Those who have other factors that affect drug absorption, distribution, metabolism, excretion, etc;\n16. Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection;\n17. Allergic constitution, including severe drug allergies or a history of drug allergies, known to be sensitive to experimental drugs or drugs Individuals allergic to any ingredient in the medication;\n18. From the screening stage to the occurrence of acute illness or concomitant medication before the study drug;\n19. Pregnant or lactating women, or women of childbearing age who test positive for pregnancy;\n20. Researchers believe that there are other factors that are not suitable for participating in this experiment.","45 Years",{"count":51,"type":22},18,[25],"This study is a non-randomized, open label trial aimed at evaluating the drug interaction between Buagafuran capsules and voriconazole tablets in Chinese adult healthy participants.The research period is 7 days in total.",[55],"Drug Drug Interaction (DDI)","2026-03-03",{"date":58,"type":33},"2026-03-09",{"date":60,"type":22},"2026-04",{"date":62,"type":22},"2026-05",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"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":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":41},"100534806","phase-3-phase--clinical-trial-of-buagafuran-capsules-in-the-treatment-of-gad-100534806","NCT06243614","Phase Ⅲ Clinical Trial of Buagafuran Capsules in the Treatment of GAD","Safety and Efficacy of Buagafuran Capsules in the Treatment of Generalized Anxiety Disorder: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Flexible-dose Phase Ⅲ Clinical Trial","BGFN-2022-01","Inclusion Criteria:\n\n1. Outpatients aged 18-65 years old, of both sexes;\n2. Met the diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for generalized anxiety disorder (GAD) and confirmed by the Brief International Neuropsychiatric Interview (M.I.N.I.);\n3. The patient requires psychiatric medication;\n4. Hamilton Anxiety Scale (HAMA) score ≥20, Hamilton Depression Scale (HAMD-17) score ≤2, Clinical Global Impression Scale (CGI-S) score ≥4 at screening and baseline Points;\n5. Able to understand and voluntarily participate in this trial, signed informed consent.\n\nExclusion Criteria:\n\n1. Patients with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3;\n2. Patients with HAMD-17 \\> 17;\n3. Patients whose HAMA scores decreased by ≥20% in the baseline period compared with the screening period:\n4. Those who met the DSM-5 diagnostic criteria for other mental disorders except GAD;\n5. Patients with previous history of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorder, factitious disorder and somatoform disorder; There were severe personality disorders, especially antisocial, borderline, or histrionic personality disorder, which were judged by the investigator to affect the patient's adherence to the study protocol;\n6. Alcohol or drug abuse or dependence within 180 days before screening;\n7. With severe or unstable has clinical significance of somatic disease, including any cardiovascular, cancer, kidney, respiratory, endocrine (including abnormal thyroid function), digestion, blood (such as with bleeding tendency) or nervous system diseases;\n8. Patients whose physical examination or vital signs were abnormal and clinically significant (e.g. inadequately controlled hypertension, systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n9. Patients with a history of epilepsy or any other disease that may induce seizures, except convulsions caused by febrile convulsions in children;\n10. Important abnormalities in laboratory tests during the screening period, such as abnormal liver function tests (alanine aminotransferase or aspartate transaminase \\> 2 times the normal value); Renal insufficiency (blood urea nitrogen or creatinine \\> 1.2 times the upper limit of normal);\n11. Clinically significant abnormalities on electrocardiography (QT interval corrected by Fridericia method: ≥450 ms for men or ≥470 ms for women) or conditions deemed ineligible by the investigators;\n12. Patients who had undergone psychiatric surgery, electroconvulsive therapy or transcranial magnetic stimulation within 90 days before screening;\n13. Patients treated with β-blockers within 90 days before screening；\n14. Patients with severe hypersensitivity, or allergic to at least 2 kinds of drugs (including photosensitivity);\n15. Patients who had previously used two or more antidepressants and\u002For benzodiazepines at a clinically appropriate dose for at least 4 weeks but were still ineffective;\n16. Receiving systemic psychotherapy or other non-pharmacological treatments (e.g., acupuncture, hypnosis, or phototherapy) within 6 weeks before the baseline visit;\n17. Those who had used benzodiazepines within -7 to -1 days before screening, such as lorazepam, oxazepam, and alprazolam for less than 5 half-lives; The use of benzodiazepines with longer half-lives, such as diazepam, clonazepam, nitrazepam, estazolam, and flurazepam, not more than 5 half-lives or less than 30 days from the screening period, or the use of barbiturates not more than 5 half-lives or less than 30 days from the screening period;\n18. Patients treated with monoamine oxidase inhibitors within -7 to 1 day before screening; Patients treated with fluoxetine within 30 days before screening;\n19. Patients using antipsychotics, antidepressants and mood stabilizers with less than 5 half-lives before the baseline washout period;\n20. Patients who discontinued traditional Chinese medicine, melatonin, and St. John's wort for less than 3 days before the baseline visit;\n21. In the experimental drug delivery within 7 days before and during the test, cannot fast grapefruit or grapefruit juice;\n22. Women during pregnancy or lactation experiments have fertility requirement (including men), and not to the male, the female patients is safe and effective contraceptive measures;\n23. Unable to take medicine as prescribed;\n24. Participants enrolled in other clinical trials within 90 days before screening;\n25. Patients with other conditions deemed by the investigator to be ineligible for enrollment.","65 Years",{"count":74,"type":22},410,[76],"PHASE3","A placebo-controlled superiority design was used to evaluate the efficacy of 60-120 mg\u002F day of Buagafuran capsules in the treatment of GAD.",[28],"RECRUITING","2024-02-04",{"date":82,"type":33},"2024-02-06",{"date":84,"type":33},"2023-07-24",{"date":86,"type":22},"2027-06-30",{"name":39,"class":40},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":41},"100534808","phase-3-phase-3-clinical-trial-of-buagafuran-capsules-in-the-treatment-of-gad-100534808","NCT06243640","Phase 3 Clinical Trial of Buagafuran Capsules in the Treatment of GAD","Safety and Efficacy of Buagafuran Capsules in the Treatment of Generalized Anxiety Disorder: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Fixed-dose Phase Ⅲ Clinical Trial","BGFN-2022-02",{"count":96,"type":22},504,[76],"A placebo-controlled superiority design was used to evaluate the efficacy of 60 mg\u002F day or 120 mg\u002F day of Buagafuran capsules in the treatment of GAD",[28],{"date":82,"type":33},{"date":102,"type":33},"2023-07-25",{"date":86,"type":22},{"name":39,"class":40},""]