[Translation] A single-center, randomized, open-label, two-dose, single-dose, four-period, completely repeated crossover fasting bioequivalence study of lercanidipine hydrochloride tablets in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,比较在空腹状态下口服受试制剂盐酸乐卡地平片(规格:10mg,持证商:福建省宝诺医药研发有限公司)与参比制剂盐酸乐卡地平片(规格:10mg,持证商:Recordati S.P.A.,商品名:再宁平®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察空腹状态下受试制剂盐酸乐卡地平片和参比制剂盐酸乐卡地平片在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the pharmacokinetic behavior of the test preparation Lercanidipine Hydrochloride Tablets (Specification: 10 mg, licensee: Fujian Province Baonuo Pharmaceutical Research and Development Co., Ltd.) and the reference preparation Lercanidipine Hydrochloride Tablets (Specification: 10 mg, licensee: Recordati S.P.A., trade name: Zainingping®) in healthy subjects after oral administration in the fasting state, and evaluate the bioequivalence of the two preparations.
Secondary purpose: Observe the safety of the test preparation Lercanidipine Hydrochloride Tablets and the reference preparation Lercanidipine Hydrochloride Tablets in healthy subjects in the fasting state.