[Translation] A single-center, randomized, open-label, two-dose, fasting and postprandial, single-dose, 2-sequence, 4-period, repeated crossover bioequivalence study of ezetimibe atorvastatin calcium tablets developed by Zhejiang Huayuan Pharmaceutical Co., Ltd. and ATOZET® marketed by Merck Sharp & Dohme in healthy subjects
以浙江花园药业有限公司持有的依折麦布阿托伐他汀钙片(规格:10 mg/10 mg)为受试制剂,以Merck Sharp & Dohme上市的依折麦布阿托伐他汀钙片(ATOZET®,规格:10 mg/10 mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。
[Translation] The test preparation was ezetimibe atorvastatin calcium tablets (specification: 10 mg/10 mg) owned by Zhejiang Huayuan Pharmaceutical Co., Ltd., and the reference preparation was ezetimibe atorvastatin calcium tablets (ATOZET®, specification: 10 mg/10 mg) marketed by Merck Sharp & Dohme. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.