[Translation] Study plan for a single-center, randomized, open-label, two-dose, single-dose, two-period, double-crossover fasting/fed bioequivalence trial of metformin hydrochloride extended-release tablets in healthy subjects
德州博诚制药有限公司生产的盐酸二甲双胍缓释片(规格:1000mg),以Santarus Inc 持有的盐酸二甲双胍缓释片(规格:1000mg)作为参比制剂,以药动学参数为指标比较两种制剂生物等效性,并评价两制剂体内安全性。
[Translation] The metformin hydrochloride sustained-release tablets (specification: 1000 mg) produced by Dezhou Bocheng Pharmaceutical Co., Ltd. were used as the reference preparation, and the pharmacokinetic parameters were used as indicators to compare the bioequivalence of the two preparations and evaluate the in vivo safety of the two preparations.