[Translation] Pilot test: randomized, open, single dose, two preparations, two cycles, two sequences, cross bioequivalence of ezetimibe atorvastatin calcium tablets (10mg/20mg) in healthy subjects under fasting and fed states sexual pretest
Formal trial: randomized, open-label, single-dose, two-dose, three-period, three-sequence, partly repeated cross-over biological trials of ezetimibe atorvastatin calcium tablets (10mg/20mg) in healthy subjects under fasting and postprandial states equivalence test
主要目的:比较空腹和餐后单次给药条件下,福建东瑞制药有限公司生产的依折麦布阿托伐他汀钙片(规格:10mg/20mg,受试制剂)与Merck Sharp & Dohme持证的依折麦布阿托伐他汀钙片(规格:10mg/20mg,参比制剂)在健康受试者中吸收程度和速度的差异。通过主要药代动力学参数,评价两者是否具有生物等效性。
次要目的:通过观察健康受试者单次口服受试制剂或参比制剂后的安全性指标,评价依折麦布阿托伐他汀钙片的安全性。
[Translation] Main purpose: To compare the Ezetimibe Atorvastatin Calcium Tablets produced by Fujian Dongrui Pharmaceutical Co., Ltd. (specification: 10mg/20mg, test preparation) with Merck Sharp & Dohme under the conditions of fasting and postprandial single administration. Ezetimibe Atorvastatin Calcium Tablets (specification: 10mg/20mg, reference preparation) was verified to be different in the degree and speed of absorption in healthy subjects. Through the main pharmacokinetic parameters, evaluate whether the two have bioequivalence.
Secondary purpose: To evaluate the safety of Ezetimibe Atorvastatin Calcium Tablets by observing the safety indicators of healthy subjects after a single oral administration of the test preparation or the reference preparation.