Xinxiang Zhongjie Pharmaceutical Co. Ltd.

Primary objective: This study used sitagliptin metformin extended-release tablets (specifications: sitagliptin phosphate 50mg (calculated as C16H15F6N5O) and metformin hydrochloride 500mg) produced by Henan Zhongjie Pharmaceutical Co., Ltd. as the test preparation and sitagliptin metformin extended-release tablets (trade name: Janumet Xr, specifications: 50mg/500mg calculated as sitagliptin/metformin hydrochloride) certified by Merck Sharp and Dohme Corp as the reference preparation to conduct a human bioequivalence study under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Main purpose: This study used sitagliptin metformin extended-release tablets (specifications: sitagliptin phosphate 100mg (calculated as C16H15F6N5O ) and metformin hydrochloride 1000mg) produced by Henan Zhongjie Pharmaceutical Co., Ltd. as the test preparation and sitagliptin metformin extended-release tablets (trade name: Janumet Xr, specifications: 100mg/1000mg calculated as sitagliptin/metformin hydrochloride) certified by Merck Sharp and Dohme Corp as the reference preparation to conduct a human bioequivalence study under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Primary objective: To use the gliclazide tablets (specification: 80 mg) of Henan Zhongjie Pharmaceutical Co., Ltd. as the test preparation and the gliclazide tablets (Diamicron®, specification: 80 mg) of Servier Laboratories Ltd. as the reference preparation, and to investigate the bioequivalence of the two preparations in healthy subjects according to the relevant provisions of the bioequivalence test. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.