/ CompletedNot Applicable [Translation] Bioequivalence study of clopidogrel and aspirin tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服氯吡格雷阿司匹林片受试制剂【规格:每片含硫酸氢氯吡格雷75mg(以氯吡格雷计)与阿司匹林100mg,申办者:甘正(海南)生物药业有限公司】和参比制剂【商品名:多立维®,规格:每片含硫酸氢氯吡格雷75mg(以氯吡格雷计)与阿司匹林100mg,持证商:Sanofi K.K.】后的药代动力学特点和生物等效性。
次要研究目的
研究氯吡格雷阿司匹林片受试制剂【规格:每片含硫酸氢氯吡格雷75mg(以氯吡格雷计)与阿司匹林100mg】和参比制剂【商品名:多立维®,规格:每片含硫酸氢氯吡格雷75mg(以氯吡格雷计)与阿司匹林100mg】在中国健康成年受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of clopidogrel aspirin tablets [Specification: each tablet contains 75 mg of clopidogrel bisulfate (calculated as clopidogrel) and 100 mg of aspirin, applicant: Ganzheng (Hainan) Biopharmaceutical Co., Ltd.] and the reference formulation [trade name: Duoliwei®, specification: each tablet contains 75 mg of clopidogrel bisulfate (calculated as clopidogrel) and 100 mg of aspirin, licensee: Sanofi K.K.] in healthy Chinese adult subjects after a single oral dose under fasting and postprandial conditions.
Secondary study objectives
To study the safety of the test formulation of clopidogrel aspirin tablets [Specification: each tablet contains 75 mg of clopidogrel bisulfate (calculated as clopidogrel) and 100 mg of aspirin] and the reference formulation [trade name: Duoliwei®, specification: each tablet contains 75 mg of clopidogrel bisulfate (calculated as clopidogrel) and 100 mg of aspirin] in healthy Chinese adult subjects.
100 Clinical Results associated with Hainan Zhongyan Pharmaceutical Technology Co., Ltd.
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