[Translation] A single-dose, randomized, open-label, two-cycle, two-sequence, self-crossover design bioequivalence trial of amlodipine besylate tablets (specification: 5 mg) in healthy subjects under fasting and postprandial 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 research purpose
Study the single oral administration 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 in the fasting and postprandial state. (Trade name: Norvasc®, Specification: 5 mg, produced and licensed by Pfizer Pharmaceuticals Co., Ltd.) Pharmacokinetics in healthy adult subjects to evaluate the bioequivalence of the two preparations taken orally on an empty stomach and after a meal.
Secondary research purpose
The safety of the test preparation (T) amlodipine besylate tablets and the reference preparation (R) amlodipine besylate tablets (Norvax®) was evaluated in healthy subjects after single oral administration on an empty stomach and after a meal.