[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation of apixaban tablets (strength: 2.5 mg) and the reference formulation (Aleto®) (strength: 2.5 mg) in healthy adult subjects under fasting and fed conditions
研究空腹和餐后状态下单次口服受试制剂阿哌沙班片(规格:2.5 mg,湖南赛隆药业有限公司生产)与参比制剂阿哌沙班片(艾乐妥®,规格:2.5 mg;Bristol-Myers Squibb Manufacturing Company生产)在健康受试者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
[Translation] The pharmacokinetic characteristics of the test preparation apixaban tablets (specification: 2.5 mg, produced by Hunan Sailon Pharmaceutical Co., Ltd.) and the reference preparation apixaban tablets (Aleto®, specification: 2.5 mg; produced by Bristol-Myers Squibb Manufacturing Company) 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.