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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.SG |
First Approval Date01 Jan 2008 |
在餐后健康中国受试者中比较含氯吡格雷和阿司匹林的复方片剂与同时给予这两种药物单方制剂的生物等效性研究
[Translation] Bioequivalence study comparing a combination tablet containing clopidogrel and aspirin with the simultaneous administration of these two drugs as single drugs in healthy Chinese subjects after a meal
主要目的:确定含75 mg氯吡格雷和100 mg肠溶ASA的复方片剂(受试制剂)中氯吡格雷和阿司匹林(ASA)与同时给予单方市售片剂(参比制剂)在健康中国受试者中餐后状态下的生物等效性 次要目的:评价两种制剂的临床安全性
[Translation] Primary objective: To determine the bioequivalence of clopidogrel and aspirin (ASA) in a combination tablet containing 75 mg clopidogrel and 100 mg enteric-coated ASA (test formulation) with the concomitant administration of a single commercially available tablet (reference formulation) in healthy Chinese subjects in the fed state Secondary objective: To evaluate the clinical safety of the two formulations
在健康中国受试者中比较含氯吡格雷和肠溶阿司匹林的复方片剂与同时给予这两种药物单方制剂的生物等效性研究
[Translation] Bioequivalence study comparing a combination tablet containing clopidogrel and enteric-coated aspirin with the simultaneous administration of these two drugs as single-drug formulations in healthy Chinese subjects
主要目的:确定含75 mg 氯吡格雷和100 mg 肠溶ASA 的复方片剂ComPlavin®(受试制剂)中氯吡格雷和阿司匹林(ASA)与同时给予单方市售片剂(参比制剂)在健康中国受试者中的生物等效性 次要目的:评价两种制剂的临床安全性
[Translation] Primary objective: To determine the bioequivalence of clopidogrel and aspirin (ASA) in a combination tablet containing 75 mg clopidogrel and 100 mg enteric-coated ASA (ComPlavin®, test formulation) with a single commercially available tablet (reference formulation) in healthy Chinese subjects Secondary objective: To evaluate the clinical safety of the two formulations
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