[Translation] A single-dose, randomized, open-label, two-period, double-crossover, fasting and fed bioequivalence study of metformin glibenclamide tablets (II) (500 mg/5 mg) produced by Sanmenxia Sanowei Pharmaceutical Co., Ltd. and metformin glibenclamide tablets (trade name: GlucovanceTM, 500 mg/5 mg) certified by Merk SANTE S.A.S in healthy subjects
主要研究目的:以 Merk SANTE S.A.S 持证的二甲双胍格列本脲片(商品名:GlucovanceTM)为参比制剂,以三门峡赛诺维制药有限公司生产的二甲双胍格列本脲片(Ⅱ)为受试制剂,通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the certified metformin glibenclamide tablets (trade name: GlucovanceTM) of Merk SANTE S.A.S as the reference preparation and the metformin glibenclamide tablets (II) produced by Sanmenxia Sanowei Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in humans 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 Chinese subjects.