[Translation] Fasting: A single-center, randomized, open-label study of ezetimibe tablets developed by Beijing Yabao Biopharmaceutical Co., Ltd. and Ezetrol/Ezetrol® licensed by MSD PHARMA (Singapore) Pte. Ltd. was conducted in healthy subjects. , two-preparation, fasting, single-dose, two-cycle, double-crossover bioequivalence study
After meal: A single-center, randomized, randomized controlled trial of Ezetrol/Ezetrol® licensed by MSD PHARMA (Singapore) Pte. Ltd., developed by Beijing Yabao Biopharmaceutical Co., Ltd. Open-label, two-formulation, prandial, single-dose, three-sequence, three-cycle, partially replicated crossover bioequivalence study
以北京亚宝生物药业有限公司生产的依折麦布片(规格:10mg)为受试制剂,以MSD PHARMA(Singapore) Pte. Ltd.上市的依折麦布片(Ezetrol/益适纯®,规格:10mg)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] Ezetimibe tablets (specification: 10mg) produced by Beijing Yabao Biopharmaceutical Co., Ltd. were used as the test preparation, and ezetimibe tablets (Ezetrol/Yishichun®) marketed by MSD PHARMA (Singapore) Pte. Ltd. , specification: 10 mg) is the reference preparation. The pharmacokinetic parameters and relative bioavailability of single administration of the two preparations under fasting and postprandial conditions are examined to evaluate whether the two preparations are bioequivalent. The safety and tolerability of both formulations in healthy humans were also evaluated.