Shijiazhuang Puli Pharmaceutical Co Ltd.

Sitagliptin Metformin Tablets (I) (50 mg/500 mg) produced by Shijiazhuang Puli Pharmaceutical Co., Ltd. was used as the test preparation, and Sitagliptin Metformin Tablets (I) (Janumet®, 50 mg/500 mg) produced by Patheon Puerto Rico, Inc. (Manati) (United States) was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent, and the safety of the two preparations in healthy subjects was evaluated.

Sitagliptin Metformin Tablets (II) (50 mg/850 mg) produced by Shijiazhuang Puli Pharmaceutical Co., Ltd. was used as the test preparation, and Sitagliptin Metformin Tablets (II) (Janumet®, 50 mg/850 mg) produced by Patheon Puerto Rico, Inc. (Manati) (United States) was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration under fasting and postprandial conditions were investigated to evaluate whether the two preparations were bioequivalent, and the safety of the two preparations in healthy subjects was evaluated.

Primary objective To compare the differences in absorption extent and speed between empagliflozin tablets (25mg) provided by Shijiazhuang Puli Pharmaceutical Co., Ltd. and empagliflozin tablets (25mg, trade name: Jardiance®) certified by Boehringer Ingelheim International GmbH in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary objective To evaluate the safety of empagliflozin tablets (25mg) provided by Shijiazhuang Puli Pharmaceutical Co., Ltd. and empagliflozin tablets (25mg, trade name: Jardiance®) certified by Boehringer Ingelheim International GmbH in healthy adults under fasting and postprandial administration conditions.