[Translation] A single-dose, randomized, open-label, crossover, fasting and fed bioequivalence study of empagliflozin tablets in healthy Chinese subjects
主要研究目的:以Boeheringer Ingelheim International GmbH持证的恩格列净片(规格:10 mg,商品名:欧唐静®)为参比制剂,以康臣药业(内蒙古)有限责任公司研发的恩格列净片(规格:10 mg)为受试制剂,通过单中心、随机、开放、单次给药、两周期、双交叉设计的临床研究来评价两种制剂在空腹和餐后状态下的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康成年受试者中的安全性。
[Translation] The main purpose of the study is to use the empagliflozin tablets (specification: 10 mg, trade name: Otangjing®) certified by Boeheringer Ingelheim International GmbH as the reference preparation and the empagliflozin tablets (specification: 10 mg) developed by Kangchen Pharmaceutical (Inner Mongolia) Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting and postprandial state through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy adult subjects in China.