[Translation] A single-center, open, balanced, randomized, single-dose, two-period, double-crossover bioequivalence study of trimetazidine hydrochloride tablets in healthy volunteers on fasting and fed diet
主要目的:比较空腹及餐后给药条件下,湖北四环制药有限公司提供的盐酸曲美他嗪片(20mg/片)与LES LABORATOIRES SERVIER生产的盐酸曲美他嗪片(20mg/片,商品名:VASOREL®)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。 次要目的:评价空腹及餐后给药条件下,湖北四环制药有限公司提供的盐酸曲美他嗪片(20mg/片)的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of trimetazidine hydrochloride tablets (20 mg/tablet) provided by Hubei Sihuan Pharmaceutical Co., Ltd. and trimetazidine hydrochloride tablets (20 mg/tablet, trade name: VASOREL®) produced by LES LABORATOIRES SERVIER in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary objective: To evaluate the safety of trimetazidine hydrochloride tablets (20 mg/tablet) provided by Hubei Sihuan Pharmaceutical Co., Ltd. under fasting and postprandial administration conditions.