[Translation] An open, randomized, single-dose, three-period, three-sequence, partially repeated crossover bioequivalence study of lacidipine tablets in healthy subjects under fasting state and open, randomized, single-dose, two-period, double crossover fed state
主要目的:比较空腹及餐后给药条件下,哈药集团三精明水药业有限公司提供的拉西地平片(4 mg/片)与GLAXOSMITHKLINE,S.A持证的拉西地平片(4 mg/片,商品名:Lacipil®)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,哈药集团三精明水药业有限公司提供的拉西地平片(4 mg/片)与GLAXOSMITHKLINE,S.A持证的拉西地平片(4 mg/片,商品名:Lacipil®)的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of Lacidipine Tablets (4 mg/tablet) provided by Harbin Pharmaceutical Group Sanjingmingshui Pharmaceutical Co., Ltd. and Lacidipine Tablets (4 mg/tablet, trade name: Lacipil®) licensed by GLAXOSMITHKLINE, S.A. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary objective: To evaluate the safety of Lacidipine Tablets (4 mg/tablet) provided by Harbin Pharmaceutical Group Sanjingmingshui Pharmaceutical Co., Ltd. and Lacidipine Tablets (4 mg/tablet, trade name: Lacipil®) licensed by GLAXOSMITHKLINE, S.A. under fasting and postprandial administration conditions.