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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date18 Aug 2022 |
Efficacy of Bupropion-Dextromethorphan fixed dose combination versus Sertraline in major depressive disorder patients: a non-inferiority randomised controlled trial - NIL
Start Date15 Oct 2024 |
Sponsor / Collaborator- |
右美沙芬安非他酮缓释片人体生物等效性研究预试验方案
[Translation] Preliminary study plan for bioequivalence study of dextromethorphan and bupropion sustained-release tablets in humans
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 Therapeutics, Inc.，生产商为Patheon（part of Thermo Fisher Scientific）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] The main purpose of the study is to use Dextromethorphan Bupropion Sustained-Release Tablets (Specifications: 45 mg (in C18H25NO·HBr·H2O)/105 mg (in C13H18ClNO·HCl)) developed and produced by Jiangsu Enhua Pharmaceutical Co., Ltd. as the test preparation, and Dextromethorphan Bupropion Sustained-Release Tablets (AUVELITY®, Specifications: 45 mg (in C18H25NO·HBr·H2O)/105 mg (in C13H18ClNO·HCl)) produced by Patheon (part of Thermo Fisher Scientific) as the reference preparation to study the absorption rate and extent of the two preparations after a single fasting/postprandial oral administration in healthy adult subjects in China, evaluate the bioequivalence between the two preparations and provide a reference for formal trials.
Secondary purpose of the study: To evaluate the safety of the test and reference preparations of Dextromethorphan Bupropion Sustained-Release Tablets after a single fasting/postprandial oral administration in healthy subjects.
[Translation] Preliminary study on bioequivalence of dextromethorphan and bupropion sustained-release tablets in humans
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] The main purpose of the study is to use Dextromethorphan Bupropion Sustained-Release Tablets (Specifications: 45 mg (in C18H25NO·HBr·H2O)/105 mg (in C13H18ClNO·HCl)) developed and produced by Jiangsu Enhua Pharmaceutical Co., Ltd. as the test preparation, and Dextromethorphan Bupropion Sustained-Release Tablets (AUVELITY®, Specifications: 45 mg (in C18H25NO·HBr·H2O)/105 mg (in C13H18ClNO·HCl)) developed and produced by Jiangsu Enhua Pharmaceutical Co., Ltd. as the reference preparation, to study the absorption rate and extent of the two preparations after a single fasting/postprandial oral administration in healthy adult subjects in China, evaluate the bioequivalence between the two preparations and provide a reference for formal trials.
Secondary purpose of the study: to evaluate the safety of the test preparation and reference preparation of Dextromethorphan Bupropion Sustained-Release Tablets after a single fasting/postprandial oral administration in healthy subjects.
100 Clinical Results associated with DAT x adrenergic receptor x σ1 receptor x CYP2D6 x NMDA receptor
100 Translational Medicine associated with DAT x adrenergic receptor x σ1 receptor x CYP2D6 x NMDA receptor
0 Patents (Medical) associated with DAT x adrenergic receptor x σ1 receptor x CYP2D6 x NMDA receptor
