[Translation] A single-dose, randomized, open-label, two-period, two-sequence, self-crossover bioequivalence study of amlodipine besylate tablets (specification: 5 mg) in healthy subjects under fasting and fed conditions
主要研究目的
研究空腹及餐后状态下单次口服受试制剂苯磺酸氨氯地平片(规格:5mg,上海华源安徽仁济制药有限公司生产并持证)与参比制剂苯磺酸氨氯地平片(商品名:络活喜®,规格:5mg,辉瑞制药有限公司生产并持证)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
评价健康受试者空腹和餐后单次口服受试制剂(T)苯磺酸氨氯地平片和参比制剂(R)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 amlodipine besylate tablets (specification: 5 mg, produced and certified by Shanghai Huayuan Anhui Renji Pharmaceutical Co., Ltd.) and the reference preparation amlodipine besylate tablets (trade name: Norvasc®, specification: 5 mg, produced and certified by Pfizer Pharmaceutical Co., Ltd.) in healthy adult subjects after single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations after fasting and fed oral administration.
Secondary study objectives
To evaluate the safety of the test preparation (T) amlodipine besylate tablets and the reference preparation (R) amlodipine besylate tablets (Norvasc®) after single oral administration in fasting and fed state in healthy subjects.