[Translation] Preliminary study: Randomized, open, single-dose, two-formulation, two-period, two-sequence, crossover bioequivalence preliminarily study of ezetimibe atorvastatin calcium tablets (10mg/20mg) in healthy subjects in the fasting and postprandial state
Formal study: Randomized, open, single-dose, two-formulation, three-period, three-sequence, partially repeated crossover bioequivalence study of ezetimibe atorvastatin calcium tablets (10mg/20mg) in healthy subjects in the fasting and postprandial state
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] Primary objective: To compare the differences in the extent and rate of absorption of ezetimibe atorvastatin calcium tablets (specifications: 10mg/20mg, test preparation) produced by Fujian Dongrui Pharmaceutical Co., Ltd. and ezetimibe atorvastatin calcium tablets (specifications: 10mg/20mg, reference preparation) certified by Merck Sharp & Dohme in healthy subjects under the conditions of single administration on an empty stomach and after a meal. To evaluate whether the two are bioequivalent through the main pharmacokinetic parameters.
Secondary objective: 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.