[Translation] A single-center, single-dose, 2-formulation, 2-period, 2-sequence, open-label, randomized, crossover average bioequivalence study of trimetazidine hydrochloride tablets in healthy subjects after fasting and feeding
主要试验目的:在健康受试者体内,分别在空腹和餐后条件下,以施维雅(天津)制药有限公司生产的盐酸曲美他嗪片(商品名:万爽力®;规格:20 mg)为参比制剂,研究北京嘉林药业股份有限公司研制的盐酸曲美他嗪片(规格:20 mg)的吸收速度与吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要试验目的:观察健康受试者口服受试制剂和参比制剂的安全性。
[Translation] The main purpose of the study is to study the absorption rate and extent of trimetazidine hydrochloride tablets (specification: 20 mg) developed by Beijing Jialin Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects, using trimetazidine hydrochloride tablets (trade name: Wanshuangli®; specification: 20 mg) produced by Servier (Tianjin) Pharmaceutical Co., Ltd. as the reference preparation, and to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation when taken orally in healthy subjects.