[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence trial evaluating the investigational formulation, levamlodipine besylate tablets (5 mg), and the reference formulation, amlodipine besylate tablets (Norvasc®, 10 mg), in healthy adult participants under fasting and postprandial conditions.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂苯磺酸左氨氯地平片(规格:5 mg,辰欣药业股份有限公司生产)与参比制剂苯磺酸氨氯地平片(络活喜®,规格:10 mg,晖致制药(大连)有限公司生产)在健康试验参与者体内的药代动力学,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要研究目的:评估受试制剂苯磺酸左氨氯地平片(规格:5 mg)和参比制剂苯磺酸氨氯地平片(络活喜®,规格:10 mg)在健康试验参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation, levamlodipine besylate tablets (5 mg, manufactured by Chenxin Pharmaceutical Co., Ltd.), and the reference formulation, amlodipine besylate tablets (Norvasc®, 10 mg, manufactured by Huizhi Pharmaceutical (Dalian) Co., Ltd.), in healthy trial participants under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting and postprandial conditions.
Secondary objective: To evaluate the safety of the test formulation, levamlodipine besylate tablets (5 mg), and the reference formulation, amlodipine besylate tablets (Norvasc®, 10 mg), in healthy trial participants.