Shijiazhuang Puli Pharmaceutical Co Ltd.

Cimetidine tablets (specification: 0.2 g) developed by Hebei Xinshi Pharmaceutical Co., Ltd. were used as the test preparation, and cimetidine tablets (trade name: Tagamet HB®, specification: 0.2 g) from Medtech Products Inc. were 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. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Primary objective: Using dapagliflozin tablets (specification: 10 mg) produced by Shijiazhuang Puli Pharmaceutical Co., Ltd. as the test preparation, and using dapagliflozin tablets (trade name: Andatang, specification: 10 mg) certified by AstraZeneca AB as the reference preparation, a human bioequivalence study was conducted in the fasting/postprandial state to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Main purpose To compare the differences in absorption extent and speed between metformin empagliflozin tablets (VI) provided by Shijiazhuang Puli Pharmaceutical Co., Ltd. (each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin) and metformin empagliflozin tablets (VI) certified by Boehringer Ingelheim International GmbH (each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin, trade name: Oushuangjing®) in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary objective To evaluate the safety of metformin empagliflozin tablets (VI) (each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin) provided by Shijiazhuang Puli Pharmaceutical Co., Ltd. and metformin empagliflozin tablets (VI) (each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin, trade name: Oushuangjing®) certified by Boehringer Ingelheim International GmbH in healthy adults under fasting and postprandial administration conditions.