[Translation] A randomized, open-label, two-dose, single-dose, four-period, completely repeated crossover bioequivalence study of ezetimibe and atorvastatin calcium tablets (II) in healthy subjects under fasting and fed conditions
主要研究目的:
以湖北午时药业股份有限公司研发的依折麦布阿托伐他汀钙片(Ⅱ)(规格:10 mg/20 mg)为受试制剂,Merck Sharp & Dohme B.V.生产的依折麦布阿托伐他汀钙片(商品名:Atozet®,规格:10 mg/20 mg)为参比制剂,分别考察空腹和餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数,评价两制剂的生物等效性。
次要研究目的:
观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main research purpose:
Using Ezetimibe Atorvastatin Calcium Tablets (II) (Specification: 10 mg/20 mg) developed by Hubei Wushi Pharmaceutical Co., Ltd. as the test preparation and Ezetimibe Atorvastatin Calcium Tablets (trade name: Atozet®, specification: 10 mg/20 mg) produced by Merck Sharp & Dohme B.V. as the reference preparation, the pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects under fasting and postprandial conditions were investigated to evaluate the bioequivalence of the two preparations.
Secondary research purpose:
Observe the safety of the test preparation and the reference preparation in healthy subjects.