[Translation] A single-center, randomized, open-label, four-period, two-sequence, fully repeated, single-dose fasting bioequivalence study of lercanidipine hydrochloride tablets in healthy volunteers
主要目的:本研究以福建海西新药创制股份有限公司的盐酸乐卡地平片(规格:10mg)为受试制剂,按生物等效性研究的有关规定,以原研厂家Recordati S.P.A.持有的盐酸乐卡地平片(规格:10 mg,商品名:再宁平®)为参比制剂,评估受试制剂和参比制剂在空腹条件下给药后的生物等效性。
次要目的:观察受试制剂盐酸乐卡地平片和参比制剂盐酸乐卡地平片(再宁平®)在健康受试者中的安全性。
[Translation] Primary Objective: This study used Lercanidipine Hydrochloride Tablets (10 mg) from Fujian Haixi New Drug Creation Co., Ltd. as the test formulation. In accordance with relevant bioequivalence regulations, Lercanidipine Hydrochloride Tablets (10 mg, trade name: Zainingping®) from the original manufacturer, Recordati S.P.A., served as the reference formulation. The study evaluated the bioequivalence of the test and reference formulations after administration under fasting conditions.
Secondary Objective: To investigate the safety of the test and reference formulations, Lercanidipine Hydrochloride Tablets (10 mg, trade name: Zainingping®), in healthy volunteers.