Wuxi Kaifu Pharmaceutical Co. Ltd.

The phenarenic acid tablets developed by Wuxi Kaifu Pharmaceutical Co., Ltd. were used as the test preparation, and the phenarenic acid tablets (trade name: Kerendia®) certified by Bayer AG were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations were investigated in the fasting and postprandial state, and the bioequivalence of the two preparations was evaluated. The safety of the test and reference preparations of phenarenic acid tablets was evaluated after a single oral administration on an empty stomach or postprandial basis in healthy Chinese subjects.

To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of apixaban tablets 2.5 mg (strength: 2.5 mg, Wuxi Kaifu Pharmaceutical Co., Ltd.) and the reference formulation 2.5 mg (trade name: Eliquis®, strength: 2.5 mg, licensee: Bristol-Myers Squibb Manufacturing Company) in healthy Chinese subjects under fasting and fed conditions.

The pharmacokinetics of the test preparation, apixaban tablets (specification: 2.5 mg, produced by Wuxi Kaifu Pharmaceutical Co., Ltd.) and the reference preparation, apixaban tablets ("Aileto®", specification: 2.5 mg, produced by Bristol-Myers Squibb Company, provided by Wuxi Kaifu Pharmaceutical Co., Ltd.) were studied in healthy subjects after a single oral dose in the fasting and fed states, and the bioequivalence of the two preparations after oral administration in the fasting and fed states was evaluated.