[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, self-crossover bioequivalence study of fasting and fed oral amlodipine besylate tablets in healthy Chinese volunteers
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:5mg,广东万泰科创药业有限公司提供)与参比制剂苯磺酸氨氯地平片(络活喜®;规格:10mg;持证商:辉瑞制药有限公司)在健康成年受试者体内的药代动力学,评价空腹和餐后口服两种制剂的生物等效性。
次要研究目的
评价中国健康受试者空腹和餐后状态下,单次口服受试制剂苯磺酸左氨氯地平片和参比制剂苯磺酸氨氯地平片(络活喜®)后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation levamlodipine besylate tablets (specification: 5mg, provided by Guangdong Wantai Kechuang Pharmaceutical Co., Ltd.) and the reference preparation amlodipine besylate tablets (Norvasc®; specification: 10mg; licensee: Pfizer Pharmaceuticals Co., Ltd.) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary study objectives
To evaluate the safety of the test preparation levamlodipine besylate tablets and the reference preparation amlodipine besylate tablets (Norvasc®) in healthy Chinese subjects in the fasting and fed state after a single oral administration.