[Translation] A single-center, randomized, open-label, two-sequence, four-period, single-dose, complete-repeat human bioequivalence study of Chinese healthy subjects taking a single dose of aspirin enteric-coated tablets in fasting and postprandial states
主要研究目的:以吉林四环制药有限公司生产的阿司匹林肠溶片(100mg)为受试制剂(T),按有关生物等效性试验的规定,以持证商为Bayer S.p.A的阿司匹林肠溶片(100mg,Bayaspirin®)为参比制剂(R)进行生物等效性试验,评价受试制剂和参比制剂的生物等效性。
次要研究目的:观察受试制剂和参比制剂阿司匹林肠溶片在健康受试者中的安全性。
[Translation] The main purpose of the study: Aspirin enteric-coated tablets (100mg) produced by Jilin Sihuan Pharmaceutical Co., Ltd. were used as the test preparation (T), and aspirin enteric-coated tablets produced by Bayer S.p.A were used as the license holder according to the relevant bioequivalence test regulations. (100mg, Bayaspirin®) was used for the bioequivalence test of the reference preparation (R) to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary research purpose: To observe the safety of the test preparation and the reference preparation aspirin enteric-coated tablets in healthy subjects.