Jiangsu Qianren Biotechnology Co., Ltd.

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of sitagliptin metformin extended-release tablets (specifications: 50mg:1000mg, applicant: Jiangsu Qianren Biotechnology Co., Ltd.) and the reference formulation (trade name: Janumet®XR, specifications: 50mg:1000mg, licensee: Merck Sharp and Dohme LLC) after a single oral dose under fasting conditions in healthy Chinese adult subjects. Secondary study objectives To study the safety of the test formulation of sitagliptin metformin extended-release tablets (specifications: 50mg:1000mg) and the reference formulation (trade name: Janumet®XR, specifications: 50mg:1000mg) in healthy Chinese adult subjects.

Main purpose of the study: Using Acipimox Capsules of Jiangsu Qianren Biotechnology Co., Ltd. as the test preparation and Acipimox Capsules of Pfizer Limited as the reference preparation, a single-center, randomized, open, single-dose, two-period crossover design was used to evaluate the bioequivalence of the two preparations in Chinese healthy subjects in the fasting and postprandial states. Secondary purpose of the study: Observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of empagliflozin metformin extended-release tablets (specification: 10mg/1000mg, applicant: Jiangsu Qianren Biotechnology Co., Ltd.) and the reference formulation (trade name: Synjardy®XR, specification: 10mg/1000mg, licensee: Boehringer Ingelheim Pharmaceuticals, Inc) after a single oral dose under fasting and postprandial conditions in healthy Chinese adult subjects. Secondary study objectives To study the safety of the test formulation of empagliflozin metformin extended-release tablets (specification: 10mg/1000mg) and the reference formulation (trade name: Synjardy®XR, specification: 10mg/1000mg) in healthy Chinese adult subjects.