[Translation] Single-center, randomized, open-label, single-dose, two-drug, two-cycle, self-crossover, postprandial bioequivalence study of aluminum-magnesium-pirin tablets (II) in healthy humans
本次试验以广州大光制药有限公司研发的铝镁匹林片(Ⅱ)为受试制剂,按生物等效性研究的有关规定,以铝镁匹林片(Ⅱ)(Lion Corporation生产,商品名:BUFFERIN)为参比制剂,考察两种制剂的阿司匹林及水杨酸药代动力学参数和相对生物利用度,评价两者在单次给药后(餐后)是否具有生物等效性。
[Translation] In this test, Al-Mg-Pirin Tablets (Ⅱ) developed by Guangzhou Daguang Pharmaceutical Co., Ltd. was used as the test preparation. Name: BUFFERIN) as the reference preparation, investigate the pharmacokinetic parameters and relative bioavailability of aspirin and salicylic acid of the two preparations, and evaluate whether the two preparations are bioequivalent after a single administration (after a meal).