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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date25 Mar 2013 |
/ SuspendedNot ApplicableIIT A Randomized, Placebo-Controlled, Double-Blind, Crossover Comparative Study of the Effect of Acotiamide on Gastrointestinal Symptoms in Patients with Myasthenia Gravis - ACTMG
Start Date01 Sep 2024 |
Sponsor / Collaborator- |
/ CompletedNot Applicable 盐酸阿考替胺片在中国健康人群中单次给药的人体生物等效性临床试验
[Translation] A single-dose bioequivalence clinical trial of acotiamide hydrochloride tablets in healthy Chinese subjects
主要目的:以持证商为ゼリア新薬工業株式会社/アステラス製薬株式会社的盐酸阿考替胺片(商品名:Acofide®),规格:100mg)为参比制剂,以南京海纳医药科技股份有限公司研发的盐酸阿考替胺片(0.1g)为受试制剂,通过单中心、随机、开放、单次给药、两制剂、两序列、四周期、完全重复交叉设计的临床试验来评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main purpose: Taking acotiamide hydrochloride tablets (trade name: Acofide®, specification: 100mg), which is licensed by Alyas Shinsui Industrial Co., Ltd./Asui Rakusu Co., Ltd., as the reference preparation, Nanjing Haina Pharmaceutical Technology Co., Ltd. The acotiamide hydrochloride tablets (0.1g) developed by the company are the test preparations and were evaluated through a single-center, randomized, open-label, single-dose, two-preparation, two-sequence, four-cycle, fully repeated crossover design clinical trial. Bioequivalence of two formulations in fasting and postprandial states in Chinese healthy subjects.
Secondary purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.
/ Not yet recruitingPhase 4IIT Randomized placebo controlled single blind study of the effectiveness of ACOTIAMIDE in functional dyspepsia
Start Date16 Aug 2022 |
Sponsor / Collaborator- |
100 Clinical Results associated with AChE x A1R x M2 receptor x M1 receptor
100 Translational Medicine associated with AChE x A1R x M2 receptor x M1 receptor
0 Patents (Medical) associated with AChE x A1R x M2 receptor x M1 receptor