[Translation] A single-center, randomized, open-label, single-dose, fasting and fed, two-formulation, two-sequence, four-period crossover bioequivalence study of ezetimibe tablets in healthy adult Chinese subjects
主要研究目的:
考察空腹/餐后单次口服受试制剂依折麦布片(规格:10 mg,海南赛立克药业有限公司生产)与参比制剂依折麦布片(商品名:益适纯®,规格:10 mg,MSD International GmbH(Singapore Branch)生产),在中国成年健康受试者的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性。
次要研究目的:
评价空腹/餐后状态下单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the relative bioavailability of the test preparation Ezetimibe tablets (specification: 10 mg, produced by Hainan Celic Pharmaceutical Co., Ltd.) and the reference preparation Ezetimibe tablets (trade name: Yishichun®, specification: 10 mg, produced by MSD International GmbH (Singapore Branch)) in healthy adult Chinese subjects after a single oral administration on an empty stomach/after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations.
Secondary study objectives:
To evaluate the safety of the test preparation and the reference preparation in healthy adult Chinese subjects after a single oral administration on an empty stomach/after a meal.