Chengdu Hengrui Pharmaceutical Co. Ltd.

Primary objective: To investigate the pharmacokinetic characteristics of metformin glibenclamide tablets (I) (500 mg/2.5 mg) manufactured by Chengdu Hengrui Pharmaceutical Co., Ltd. and metformin glibenclamide tablets (I) (500 mg/2.5 mg) manufactured by Merck Sante s.a.s., after a single oral dose in Chinese healthy participants, and to evaluate the bioequivalence of the two formulations. Secondary objective: To evaluate the safety of the test and reference formulations of metformin glibenclamide tablets (I) (500 mg/2.5 mg) after a single oral dose in Chinese healthy participants.

A single-center, randomized, open-label, two-period, single-dose, crossover trial was conducted with fasting and fed administration to evaluate the bioequivalence and safety of sitagliptin phosphate tablets (sitagliptin, strength: 100 mg (calculated as sitagliptin) produced by Chengdu Hengrui Pharmaceutical Co., Ltd. and sitagliptin phosphate tablets (sitagliptin, trade name: Januvia®, strength: 100 mg (calculated as sitagliptin)) produced by Hangzhou Merck Pharmaceuticals Co., Ltd. after oral administration in Chinese health study participants in the fasting and fed states, providing a basis for the registration application of the test formulation.

Main study objectives To study the pharmacokinetics of the test preparation sildenafil citrate tablets (specification: 50mg, produced by Chengdu Hengrui Pharmaceutical Co., Ltd.) and the reference preparation sildenafil citrate tablets (Viagra®, specification: 50mg, produced by Pfizer Pharmaceutical Co., Ltd.) in healthy adult participants in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state Secondary study objectives To evaluate the safety of the test preparation sildenafil citrate tablets and the reference preparation sildenafil citrate tablets (Viagra®) in the fasting and fed state in healthy Chinese participants.