[Translation] A single-dose, fasting/fed, randomized, open-label, two-period crossover bioequivalence study of metformin hydrochloride tablets in Chinese healthy subjects
主要目的:评估受试制剂与参比制剂日本新薬株式会社的盐酸二甲双胍片(商品名Glycoran)在中国健康受试者中在空腹和餐后状态下的生物等效性。
次要目的: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] Primary objective: To evaluate the bioequivalence of the test formulation and the reference formulation, metformin hydrochloride tablets (trade name Glycoran) of Nippon Shinyaku Co., Ltd., in Chinese healthy subjects in the fasting and fed state.
Secondary objective: To observe the safety of the test formulation and the reference formulation in Chinese healthy subjects.