Yangling Buchang Pharmaceutical Co., Ltd.

Primary objective: According to the relevant provisions of bioequivalence test, the sitagliptin phosphate tablets (specification: 100 mg) produced by Shaanxi Buchang Pharmaceutical Co., Ltd. and commissioned by Yangling Buchang Pharmaceutical Co., Ltd. were used as the test preparation, and the sitagliptin phosphate tablets (trade name: Januvia®, specification: 100 mg) held by Merck Sharp & Dohme B.V. were used as the reference preparation to conduct a bioequivalence test to compare the bioequivalence of the two preparations under fasting and postprandial conditions. Secondary objective: To evaluate the safety of a single oral dose of the test preparation (sitagliptin phosphate tablets, T) and the reference preparation (Januvia®, R) in healthy adult subjects in China.

Tadalafil tablets (specification: 20 mg) developed by Yangling Buchang Pharmaceutical Co., Ltd. were used as the test preparation, and tadalafil tablets (trade name: Cialis®/Cialis®, specification: 20 mg) produced by Lilly del Caribe, Inc. Puerto Rico (Puerto Rico) were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.