[Translation] Bioequivalence study of metformin vildagliptin tablets (II) in Chinese healthy subjects under single-dose, randomized, open-label, two-cycle, double-crossover, fasting and postprandial conditions
主要研究目的:以 Novartis Pharma Schweiz AG持证的二甲双胍维格列汀片(II)(规格:850 mg / 50 mg,商品名:Eucreas®)为参比制剂,以山东朗诺制药有限公司生产的二甲双胍维格列汀片(II)(规格:850 mg / 50 mg)为受试制剂,通过单中心、单次给药、随机、开放、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受试者中的安全性。
[Translation] Main research purpose: Use Novartis Pharma Schweiz AG’s certified metformin vildagliptin tablets (II) (specification: 850 mg/50 mg, trade name: Eucreas®) as the reference preparation, and use the metformin vildagliptin tablets (II) produced by Shandong Langnuo Pharmaceutical Co., Ltd. Metformin Vildagliptin Tablets (II) (specification: 850 mg/50 mg) is the test preparation. The two preparations were evaluated through a single-center, single-dose, randomized, open-label, two-cycle, double-crossover design clinical study. Human bioequivalence in fasted and postprandial states.
Secondary research purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.