[Translation] A randomized, open-label, fasting and fed, single-dose, two-period, double-crossover bioequivalence study of metformin hydrochloride extended-release tablets (II) in Chinese healthy subjects
主要目的:以富祥(大连)制药有限公司生产的盐酸二甲双胍缓释片(Ⅱ)为受试制剂,按生物等效性试验的有关规定,与Watson Laboratories生产的盐酸二甲双胍缓释片(商品名:FORTAMET)对比在健康人体内的相对生物利用度,考察两制剂的人体生物等效性 次要目的:观察受试制剂盐酸二甲双胍缓释片(Ⅱ)和参比制剂盐酸二甲双胍缓释片(商品名:FORTAMET)在健康受试者中药代动力学特点和安全性
[Translation] Primary objective: To compare the relative bioavailability of metformin hydrochloride sustained-release tablets (Ⅱ) produced by Fuxiang (Dalian) Pharmaceutical Co., Ltd. in healthy volunteers with that of metformin hydrochloride sustained-release tablets (trade name: FORTAMET) produced by Watson Laboratories according to the relevant provisions of bioequivalence studies, and to investigate the bioequivalence of the two preparations in humans. Secondary objective: To observe the pharmacokinetic characteristics and safety of the test preparation metformin hydrochloride sustained-release tablets (Ⅱ) and the reference preparation metformin hydrochloride sustained-release tablets (trade name: FORTAMET) in healthy volunteers.