[Translation] A single-center, open-label, randomized, single-dose, two-formulation, two-sequence, four-period, completely repeated crossover bioequivalence study of rosuvastatin ezetimibe tablets (I) in Chinese healthy participants under fasting and fed conditions
主要目的:空腹及餐后给药条件下,比较福建东瑞制药有限公司生产的瑞舒伐他汀依折麦布片(I)(规格:10 mg / 10 mg)与Sanofi-Aventis Ireland Limited T/A SANOFI持证的瑞舒伐他汀依折麦布片(I)(规格:10 mg / 10 mg,商标名:旨立达®/Zenon®)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的:评价空腹及餐后给药条件下,瑞舒伐他汀依折麦布片(I)(10 mg / 10 mg)的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of rosuvastatin ezetimibe tablets (I) (specification: 10 mg / 10 mg) produced by Fujian Dongrui Pharmaceutical Co., Ltd. and rosuvastatin ezetimibe tablets (I) (specification: 10 mg / 10 mg, brand name: Zhilida®/Zenon®) licensed by Sanofi-Aventis Ireland Limited T/A SANOFI in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of rosuvastatin ezetimibe tablets (I) (10 mg / 10 mg) under fasting and postprandial administration conditions.