Consun Pharmaceutical (Inner Mongolia) Co., Ltd.

Primary objective: In accordance with relevant bioequivalence testing regulations, fenelazol tablets (trade name: Keshenda®, strength: 10mg) manufactured and supplied by Bayer AG (licensed manufacturer) were selected as the reference formulation for a postprandial administration bioequivalence study of the test formulation fenelazol tablets (strength: 10mg) manufactured and supplied by Kangchen Pharmaceutical (Inner Mongolia) Co., Ltd. The study aimed to compare whether the differences in the absorption rate and extent of the drug in the test formulation with those in the reference formulation were within acceptable limits, and to evaluate the bioequivalence of the two formulations under postprandial administration conditions. Secondary objective: To observe the safety of oral administration of the test formulation fenelazol tablets (strength: 10mg) and the reference formulation fenelazol tablets (trade name: Keshenda®, strength: 10mg) in healthy volunteers.

Primary objective: In accordance with relevant bioequivalence testing regulations, fenelazol tablets (trade name: Keshenda®, strength: 10mg) manufactured and supplied by Bayer AG (licensed manufacturer) were selected as the reference formulation for a fasting-administered human bioequivalence study of the test formulation fenelazol tablets (strength: 10mg) manufactured and supplied by Kangchen Pharmaceutical (Inner Mongolia) Co., Ltd. The study aimed to compare whether the differences in the absorption rate and extent of the drug in the test formulation with those in the reference formulation were within acceptable limits, and to evaluate the bioequivalence of the two formulations under fasting administration conditions. Secondary objective: To observe the safety of oral administration of the test formulation fenelazol tablets (strength: 10mg) and the reference formulation fenelazol tablets (trade name: Keshenda®, strength: 10mg) in healthy volunteers.

The main purpose of the study is to use the empagliflozin tablets (specification: 10 mg, trade name: Otangjing®) certified by Boeheringer Ingelheim International GmbH as the reference preparation and the empagliflozin tablets (specification: 10 mg) developed by Kangchen Pharmaceutical (Inner Mongolia) Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations in the fasting and postprandial state through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy adult subjects in China.