[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, four-period, completely repeated crossover fasting bioequivalence study of lercanidipine hydrochloride tablets in healthy subjects
主要目的:考察空腹条件下,在中国健康受试者中评价湖南金圃医药科技有限公司开发的盐酸乐卡地平片(20mg)与Recordati Industria Chimica e Farmaceutica S.p.A.生产的盐酸乐卡地平片(20mg;商品名:Zanidip®)的人体生物等效性。
次要目的:评价盐酸乐卡地平片受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: To investigate the bioequivalence of Lercanidipine Hydrochloride Tablets (20 mg) developed by Hunan Jinpu Pharmaceutical Technology Co., Ltd. and Lercanidipine Hydrochloride Tablets (20 mg; trade name: Zanidip®) produced by Recordati Industria Chimica e Farmaceutica S.p.A. in healthy Chinese subjects under fasting conditions.
Secondary objective: To evaluate the safety of the test and reference formulations of Lercanidipine Hydrochloride Tablets in healthy subjects.