[Translation] A bioequivalence study of amlodipine besylate orally disintegrating tablets (specification: 10 mg) in healthy subjects under fasting and postprandial states, a single-dose, randomized, open-label, two-period, two-sequence, self-crossover design
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氨氯地平口崩片(规格:10mg,深圳信立泰药业有限公司生产,广东金城金素制药有限公司持证)与参比制剂苯磺酸氨氯地平口崩片(商品名:ノルバスク®,规格:10mg,ヴィアトリス製薬株式会社生产,ヴィアトリス製薬株式会社持证)在健康成年受试者体内的药代动力学,初步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)苯磺酸氨氯地平口崩片和参比制剂(R)苯磺酸氨氯地平口崩片(ノルバスク®)后的安全性。
[Translation] Main research purpose
Study the single oral disintegration of the test preparation amlodipine besylate (specification: 10 mg, produced by Shenzhen Xinlitai Pharmaceutical Co., Ltd., licensed by Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd.) and the reference drug under fasting and postprandial states. Pharmacokinetics of Amlodipine Besylate Orally Disintegrating Tablets (trade name: Norbusku®, specification: 10mg, produced by Viatrisu Seiya Co., Ltd., licensed by Viatrisu Seiya Co., Ltd.) in healthy adult subjects, preliminary evaluation on fasting Bioequivalence of the two formulations after oral administration with food.
Secondary research purpose
To evaluate the safety of the test preparation (T) amlodipine besylate orally disintegrating tablets and the reference preparation (R) amlodipine besylate orally disintegrating tablets (ノルバスク®) in healthy subjects after a single oral administration sex.