Jiangsu Qianren Biotechnology Co., Ltd.

The main research purpose: According to the regulations on bioequivalence testing, select the certified texagliptin hydrobromide tablets (trade name: TENELIA®; specifications: 20 mg (calculated as texagliptin) from Mitsubishi Tanbei Co., Ltd. ) is a reference preparation, and the human bioequivalence of fasting and postprandial administration was conducted on the test preparation ticagliptin hydrobromide tablets (specification: 20 mg (calculated as C22H30N6OS)) produced and provided by Jiangsu Qianren Biotechnology Co., Ltd. A safety test is conducted to compare whether the difference in absorption rate and degree of drug in the test preparation and the reference preparation is within an acceptable range, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the oral administration of the test preparation Telagliptin Hydrobromide Tablets (specification: 20 mg (calculated as C22H30N6OS)) and the reference preparation Telagliptin Hydrobromide Tablets (trade name: TENELIA®) to healthy subjects. ; Specification: 20mg (calculated as texagliptin)) safety.

The main purpose of the study is to use Riociguat tablets produced by Jiangsu Qianren Biotechnology Co., Ltd. as the test preparation and Riociguat tablets certified by Bayer AG as the reference preparation. The bioequivalence of the two preparations in the fasting and fed state is evaluated through a single-center, randomized, open, single-dose, two-period crossover clinical study. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

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.