[Translation] A single-center, randomized, open-label, two-sequence, four-period, single-dose, fully repeated human bioequivalence study of oral enteric-coated aspirin tablets in Chinese healthy subjects in the fasting and fed state
研究健康受试者空腹及餐后单次口服受试制剂阿司匹林肠溶片(南京道群医药研发有限公司,规格:100mg)与参比制剂阿司匹林肠溶片(商品名:Bayaspirin®;Bayer S.p.A,规格:100mg)在吸收程度和速度方面是否存在差异,评价受试制剂和参比制剂在空腹和餐后条件下给药时的生物等效性,观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] To investigate whether there are differences in the extent and rate of absorption of the test preparation Enteric-coated Aspirin Tablets (Nanjing Daoqun Pharmaceutical Research and Development Co., Ltd., specification: 100 mg) and the reference preparation Enteric-coated Aspirin Tablets (trade name: Bayaspirin®; Bayer S.p.A., specification: 100 mg) when taken orally on an empty stomach or after a meal in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach or after a meal, and to observe the safety of the test preparation and the reference preparation in healthy subjects.