[Translation] A single-center, randomized, open-label, fasting and fed, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of levamlodipine besylate tablets in healthy Chinese adult subjects
主要研究目的:
考察单次(空腹/餐后)口服2.5mg受试制剂苯磺酸左氨氯地平片(规格:2.5mg/片,以左氨氯地平计;辽宁福源药业有限公司生产)与口服5mg参比制剂苯磺酸氨氯地平片(商品名:络活喜®;规格:5mg/片,以氨氯地平计;晖制制药(大连)有限公司生产),在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价单次(空腹/餐后)口服2.5mg受试制剂苯磺酸左氨氯地平片与口服5mg参比制剂苯磺酸氨氯地平片在中国健康成年受试者中的安全性。
[Translation] Primary Study Objective:
To investigate the relative bioavailability of a single oral dose (fasting/postprandial) of the test formulation, 2.5 mg levamlodipine besylate tablets (strength: 2.5 mg/tablet, calculated as levamlodipine; manufactured by Liaoning Fuyuan Pharmaceutical Co., Ltd.) compared to a 5 mg reference formulation, amlodipine besylate tablets (trade name: Norvasc®; strength: 5 mg/tablet, calculated as amlodipine; manufactured by Huizhi Pharmaceutical (Dalian) Co., Ltd.), in healthy Chinese volunteers. The pharmacokinetic parameters of the two formulations were analyzed, and the bioequivalence of the two formulations was evaluated to provide a reference for drug application and clinical use.
Secondary Study Objective:
To evaluate the safety of a single oral dose (fasting/postprandial) of the test formulation, 2.5 mg levamlodipine besylate tablets, compared to a 5 mg reference formulation, amlodipine besylate tablets, in healthy Chinese adult volunteers.