[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of apixaban dispersible tablets and apixaban tablets in Chinese healthy volunteers after fasting or feeding
主要目的:
以上海奥全生物医药科技有限公司提供的阿哌沙班分散片为受试制剂(2.5 mg/片),以Bristol-Myers Squibb Manufacturing Company生产的阿哌沙班片(Eliquis®,2.5mg/片)为参比制剂,比较阿哌沙班分散片和阿哌沙班片在中国健康受试者体内的药代动力学(Pharmacokinetics,PK)行为,评价空腹和餐后口服两种制剂的生物等效性。
次要目的:
1、评价中国健康受试者空腹及餐后单次口服阿哌沙班分散片和阿哌沙班片的安全性。
2、收集受试者服用阿哌沙班分散片后15 min内的感官评估问卷(包含口感、口味以及服药后的余味)。
[Translation] Main purpose:
The apixaban dispersible tablets provided by Shanghai Aoquan Biopharmaceutical Technology Co., Ltd. were used as the test preparation (2.5 mg/tablet), and the apixaban tablets (Eliquis®, 2.5 mg/tablet) produced by Bristol-Myers Squibb Manufacturing Company were used as the reference preparation to compare the pharmacokinetic (PK) behavior of apixaban dispersible tablets and apixaban tablets in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations after fasting and postprandial oral administration.
Secondary purpose:
1. To evaluate the safety of single oral administration of apixaban dispersible tablets and apixaban tablets in healthy Chinese subjects after fasting and postprandial administration.
2. To collect sensory evaluation questionnaires (including taste, flavor, and aftertaste after taking the medicine) within 15 minutes after taking the apixaban dispersible tablets.