/ CompletedNot Applicable 依折麦布阿托伐他汀钙片在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、三序列、三周期、部分重复交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, three-sequence, three-period, partially repeated crossover bioequivalence study of ezetimibe and atorvastatin calcium tablets in Chinese healthy subjects under fasting and fed conditions
按有关生物等效性试验的规定,选择持证商为 Organon Healthcare GmbH 的依折麦布阿托伐他汀钙片(商品名:Atozet®,规格:10mg/10mg)为参比制剂,对吉林省德商药业股份有限公司生产,北京满格医药科技有限公司提供的受试制剂依折麦布阿托伐他汀钙片(规格:10mg/10mg)进行空腹和餐后给药人体生物等效性预试验,评估两制剂的药代动力学特征,为正式试验设计提供参考依据。同时观察健康受试者口服受试制剂和参比制剂后的安全性。
[Translation] According to the relevant provisions of bioequivalence tests, the reference preparation was selected as Ezetimibe Atorvastatin Calcium Tablets (trade name: Atozet®, specification: 10mg/10mg) produced by Organon Healthcare GmbH, and the test preparation Ezetimibe Atorvastatin Calcium Tablets (specification: 10mg/10mg) produced by Jilin Deshang Pharmaceutical Co., Ltd. and provided by Beijing Mange Pharmaceutical Technology Co., Ltd. was used for fasting and postprandial human bioequivalence preliminary test to evaluate the pharmacokinetic characteristics of the two preparations and provide a reference for the formal test design. At the same time, the safety of healthy subjects after oral administration of the test preparation and the reference preparation was observed.
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