[Translation] A single-center, randomized, open-label, two-preparation, fasting/after-meal, single-dose, 2-sequence-4-cycle, crossover design bioequivalence study of aspirin enteric-coated tablets in Chinese healthy subjects
以广东彼迪药业有限公司生产的阿司匹林肠溶片(规格:100mg)为受试制剂,以Bayer HealthCare Manufacturing S.r.l.生产的阿司匹林肠溶片(BAYASPIRIN®,规格:100mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] Aspirin enteric-coated tablets (specification: 100mg) produced by Guangdong Biddy Pharmaceutical Co., Ltd. were used as the test preparation, and aspirin enteric-coated tablets (BAYASPIRIN®, specification: 100mg) produced by Bayer HealthCare Manufacturing S.r.l. were used as the reference preparation. Two tests were conducted. The pharmacokinetic parameters and relative bioavailability of a single dose of the preparation under fasting and postprandial conditions were evaluated to evaluate whether the two preparations were bioequivalent. The safety and tolerability of both formulations in healthy humans were also evaluated.