Shaanxi Junkeli Pharmaceutical Technology Co., Ltd.

The dapagliflozin tablets (specification: 10 mg) developed by Shaanxi Junkeli Pharmaceutical Technology Co., Ltd. were used as the test preparation, and the dapagliflozin tablets (trade name: Andatang®/FORXIGA®, specification: 10 mg) licensed by AstraZeneca AB 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 the phenarenic acid tablets developed by Shaanxi Junkeli Pharmaceutical Technology Co., Ltd. as the test preparation and the phenarenic acid tablets (trade name: Kerendia®) certified by Bayer AG as the reference preparation, the pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial state were investigated to evaluate whether the two preparations are bioequivalent. Secondary objective: To evaluate the safety of the test and reference preparations of phenarenic acid tablets after single oral administration in fasting/postprandial state in healthy Chinese subjects.