Baoding Tianhao Pharmaceutical Co., Ltd.

Main study purpose: This study aims to study the pharmacokinetic characteristics of sitagliptin metformin extended-release tablets (50 mg/500 mg) developed by Baoding Tianhao Pharmaceutical Co., Ltd. and produced by Yangling Buchang Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; sitagliptin metformin extended-release tablets (JANUMET® XR, 50 mg/500 mg based on sitagliptin/metformin hydrochloride) produced by Merck Sharp & Dohme LLC were used as the reference preparation to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations and evaluate the bioequivalence of the two preparations in humans. Secondary study purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

This study used the oseltamivir phosphate dry suspension licensed by Baoding Tianhao Pharmaceutical Co., Ltd. as the test preparation. According to the relevant provisions of the bioequivalence test, Tamiflu® licensed by Roche Registration GmbH was used as the reference preparation. The human bioequivalence test was conducted in the fasting/postprandial state to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. At the same time, the safety of the test preparation and the reference preparation in healthy subjects was observed.

This study used desvenlafaxine sustained-release tablets (specification: 50 mg) developed by Baoding Tianhao Pharmaceutical Co., Ltd. and produced by Shaanxi Buchang High-tech Pharmaceutical Co., Ltd. as the test preparation, and desvenlafaxine sustained-release tablets (specification: 50 mg) certified by Alembic Pharmaceuticals Ltd as the reference preparation. The pharmacokinetic parameters and intra-individual coefficient of variation of the test preparation and the reference preparation in healthy subjects under fasting and postprandial conditions were investigated to evaluate the bioequivalence between the two preparations. At the same time, the safety of the test preparation and the reference preparation in healthy subjects was observed.