/ RecruitingNot Applicable 阿司匹林肠溶片随机、开放、双周期、交叉设计的人体生物等效性研究
[Translation] A randomized, open-label, two-period, crossover design bioequivalence study of enteric-coated aspirin tablets in humans
1.主要研究目的
以沈阳奥吉娜药业有限公司生产的阿司匹林肠溶片为受试制剂,Bayer Health Care Manufacturing S.r.l 生产的阿司匹林肠溶片(商品名:Bayaspirin®)为参比制剂,分别进行空腹及餐后状态下人体生物利用度与生物等效性试验,比较两种制剂的生物等效性。
2.次要研究目的
观察阿司匹林肠溶片在健康成年人群中的安全性。
[Translation] 1. Main research purpose
Aspirin enteric-coated tablets produced by Shenyang Aojina Pharmaceutical Co., Ltd. were used as the test preparation, and aspirin enteric-coated tablets (trade name: Bayaspirin®) produced by Bayer Health Care Manufacturing S.r.l were used as the reference preparation. The tests were conducted under fasting and postprandial conditions respectively. Human bioavailability and bioequivalence tests compare the bioequivalence of two preparations.
2. Secondary research purpose
To observe the safety of aspirin enteric-coated tablets in healthy adults.
100 Clinical Results associated with Shenyang Aojina Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Shenyang Aojina Pharmaceutical Co., Ltd.