[Translation] A randomized, open-label, two-formulation, two-sequence, single-dose, completely repeated crossover design bioequivalence study of clopidogrel-aspirin tablets in healthy subjects under fasting and fed conditions
以北京抗创联生物制药技术研究有限公司提供的氯吡格雷阿司匹林片为受试制剂,以サノフィ株式会社生产的氯吡格雷阿司匹林片(商品名:ComPlavin)为参比制剂,按生物等效性试验研究的有关规定,评价受试制剂与参比制剂在空腹及餐后条件下健康受试者中的生物等效性。观察健康受试者在服用受试制剂氯吡格雷阿司匹林片或参比制剂氯吡格雷阿司匹林片(商品名:ComPlavin)后的安全性。
[Translation] The clopidogrel aspirin tablets provided by Beijing Kangchuanglian Biopharmaceutical Technology Research Co., Ltd. were used as the test preparation, and the clopidogrel aspirin tablets (trade name: ComPlavin) produced by Sanofi Co., Ltd. were used as the reference preparation. According to the relevant regulations of bioequivalence studies, the bioequivalence of the test preparation and the reference preparation in healthy subjects under fasting and postprandial conditions was evaluated. The safety of healthy subjects after taking the test preparation clopidogrel aspirin tablets or the reference preparation clopidogrel aspirin tablets (trade name: ComPlavin) was observed.