Saile Pharmaceutical Technology (Shanghai) Co., Ltd.

Sitagliptin metformin extended-release tablets (trade name: JANUMET XR, specification: 100mg/1000mg) and sitagliptin metformin tablets (trade name: JANUMET, specification: 50mg/500mg) Sitagliptin metformin controlled-release tablets (100mg/1000mg) and sitagliptin metformin extended-release tablets (100mg/1000mg) and sitagliptin metformin tablets (50mg/500mg) were selected for a randomized, open, four-sequence, four-period, crossover bioavailability trial under fasting and postprandial dosing conditions in healthy Chinese participants Protocol number: WBYY25071 (version date: 2 025.06.12, version number: V1.0) 34 The two were used as reference preparations to conduct fasting and postprandial human bioavailability tests on sitagliptin metformin controlled-release tablets (specifications: 100mg/1000mg) developed by Cell Pharmaceutical Technology (Shanghai) Co., Ltd., to compare the pharmacokinetics of the three preparations under postprandial conditions and evaluate the relative bioavailability, and to study the pharmacokinetics and food effect of sitagliptin metformin controlled-release tablets (specifications: 100mg/1000mg) under fasting conditions

Primary Study Objective: In accordance with bioequivalence regulations, sitagliptin metformin extended-release tablets (JANUMET XR, 100 mg/1000 mg) from MERCK SHARP AND DOHME LLC (a subsidiary of MERCK AND CO INC) was selected as the reference formulation. A postprandial bioequivalence study was conducted against the test formulation, sitagliptin metformin controlled-release tablets (100 mg/1000 mg), provided by Celler Pharmaceuticals (Shanghai) Co., Ltd., to compare the bioequivalence of the two formulations in healthy Chinese participants. Secondary Study Objective: To observe the safety of the test formulation, sitagliptin metformin controlled-release tablets (100 mg/1000 mg), and the reference formulation, sitagliptin metformin extended-release tablets (JANUMET XR, 100 mg/1000 mg), when administered orally in healthy participants.