Guizhou Tian'an Pharmaceutical Co. Ltd.

Primary Objective: To investigate the bioequivalence of dapagliflozin tablets (test formulation T, manufactured by Shuanghe Tianan Pharmaceutical (Guizhou) Co., Ltd., strength: 10 mg/tablet) and dapagliflozin tablets (reference formulation R, owned by AstraZeneca AB and manufactured by AstraZeneca Pharmaceuticals LP, trade name: Andatang®/FORXIGA®, strength: 10 mg/tablet) after oral administration of a single dose of dapagliflozin tablets (test formulation T, manufactured by Shuanghe Tianan Pharmaceutical (Guizhou) Co., Ltd.) to healthy study participants. The objective was to investigate the bioequivalence of dapagliflozin tablets (test formulation T) and reference formulation R (reference formulation R, owned by AstraZeneca AB and manufactured by AstraZeneca Pharmaceuticals LP, trade name: Andatang®/FORXIGA®) to healthy study participants after oral administration of a single dose of dapagliflozin tablets (test formulation T, manufactured by Shuanghe Tianan Pharmaceutical (Guizhou) Co., Ltd., strength: 10 mg/tablet) under fasting and fed conditions. Secondary Objective: To investigate the bioequivalence of dapagliflozin tablets (test formulation T) and reference formulation R (reference formulation R, trade name: Andatang®/FORXIGA®) to healthy study participants.

Primary objective: After a single oral dose of dapagliflozin tablets (Dapagliflozin Tablets, test preparation T, produced by Shuanghe Tianan Pharmaceutical (Guizhou) Co., Ltd., specification: 10 mg/tablet) and dapagliflozin tablets (Dapagliflozin Tablets, reference preparation R, owned by AstraZeneca AB and produced by AstraZeneca Pharmaceuticals LP, trade name: Andatang®/FORXIGA®, specification: 10 mg/tablet) was administered to healthy study participants under fasting/postprandial conditions, this pilot study mainly investigated the pharmacokinetic parameters and intra-individual coefficient of variation of the test preparation and the reference preparation in healthy study participants under fasting and postprandial conditions, and verified the rationality of the blood drug concentration analysis method, blood collection time, washout period time interval and other settings. Secondary objective: To observe the safety of the test preparation dapagliflozin tablets and the reference preparation dapagliflozin tablets (Andatang®/FORXIGA®) in healthy study participants.

Primary objective: To compare the differences in absorption degree and absorption rate between pioglitazone hydrochloride dispersible tablets (specification: 30 mg) provided by Guizhou Tianan Pharmaceutical Co., Ltd. and pioglitazone hydrochloride tablets (trade name: ACTOS®, specification: 30 mg) certified by Takeda Teba Pharmaceutical Co., Ltd. in healthy Chinese population under fasting and postprandial administration conditions using a single-center, randomized, open, two-dose, two-period crossover, single-dose, fasting and postprandial administration design. Secondary objective: To evaluate the safety of pioglitazone hydrochloride dispersible tablets (specification: 30 mg) provided by Guizhou Tianan Pharmaceutical Co., Ltd. and pioglitazone hydrochloride tablets (trade name: ACTOS®, specification: 30 mg) certified by Takeda Teba Pharmaceutical Co., Ltd. under fasting and postprandial conditions.