Shanxi Deyuantang Pharmaceutical Co. Ltd.

Dapagliflozin metformin extended-release tablets (I) (specification: 5 mg/500 mg) produced by Shanxi Deyuantang Pharmaceutical Co., Ltd. was used as the test preparation, and AstraZeneca AB's certified dapagliflozin metformin extended-release tablets (I) (trade name: Xigduo XR®, specification: 5 mg/500 mg) 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; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Primary objective: To investigate the in vivo time course of Asartan Potassium Tablets (test preparation, specification: 80 mg) produced by Shanxi Deyuantang Pharmaceutical Co., Ltd. and Asartan Potassium Tablets (reference preparation, trade name: Edabi®, specification: 80 mg) produced by Takeda Ireland Ltd. (licensed by Takeda Pharma A/S) after a single oral administration of Asartan Potassium Tablets (test preparation, specification: 80 mg) to healthy subjects, estimate their relevant pharmacokinetic parameters and relative bioavailability, evaluate their bioequivalence in the postprandial state, and provide a basis for the production registration application of the test preparation. Secondary objective: To evaluate the safety of the test preparation and reference preparation of Asartan Potassium Tablets (trade name: Edabi®) in healthy subjects.

Dapagliflozin metformin extended-release tablets (I) (specification: 10 mg/1000 mg) produced by Shanxi Deyuantang Pharmaceutical Co., Ltd. was used as the test preparation, and dapagliflozin metformin extended-release tablets (I) (trade name: Xigduo XR®, specification: 10 mg/1000 mg) produced by AstraZeneca AB 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; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.