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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date18 Aug 2022 |
[Translation] Preliminary study on human bioequivalence of dextromethorphan and bupropion sustained-release tablets
主要研究目的:以江苏恩华药业股份有限公司研制生产的右美沙芬安非他酮缓释片(规格:45mg(以C18H25NO·HBr·H2O计)/105mg(以C13H18ClNO·HCl计))为受试制剂,以持证商为Axsome公司,生产商为Patheon公司的右美沙芬安非他酮缓释片(AUVELITY®,规格:45mg(以C18H25NO·HBr·H2O计)/105mg(以C13H18ClNO·HCl计))为参比制剂,研究在中国健康成年受试者单次空腹/餐后口服两制剂的吸收速度和吸收程度,评价两制剂间的生物等效性并为正式试验提供参考。
次要研究目的:评估健康受试者单次空腹/餐后口服右美沙芬安非他酮缓释片受试制剂和参比制剂后的安全性。
[Translation] Main research purpose: Dextromethorphan bupropion sustained-release tablets (specification: 45 mg (calculated as C18H25NO·HBr·H2O)/105mg (calculated as C13H18ClNO·HCl)) developed and produced by Jiangsu Enhua Pharmaceutical Co., Ltd. The preparation under test is dextromethorphan and bupropion sustained-release tablets (AUVELITY®), which is licensed by Axsome Company and manufactured by Patheon Company. Specifications: 45 mg (based on C18H25NO·HBr·H2O)/105mg (based on C13H18ClNO· HCl (calculated as HCl)) is a reference preparation. The absorption rate and degree of absorption of the two preparations were studied in Chinese healthy adult subjects after a single oral administration on an empty stomach or after a meal, to evaluate the bioequivalence between the two preparations and to provide reference for formal trials.
Secondary study objectives: To evaluate the safety of healthy subjects after a single fasting/postprandial oral administration of the test formulation and reference formulation of dextromethorphan bupropion extended-release tablets.
A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion (AUVELITY) as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
The overall goal of this project is to collect initial human data on the effects of novel compounds on safety (interactions with an opioid drug, e.g., buprenorphine) and early efficacy signals (subjective effects on negative affect, craving, and opioid withdrawal) in OUD subjects currently in MOUD treatment with buprenorphine.
100 Clinical Results associated with DAT x adrenergic receptor x σ1 receptor x NMDA receptor x CYP2D6
100 Translational Medicine associated with DAT x adrenergic receptor x σ1 receptor x NMDA receptor x CYP2D6
0 Patents (Medical) associated with DAT x adrenergic receptor x σ1 receptor x NMDA receptor x CYP2D6