[Translation] A single-dose, randomized, open-label, two-period, two-sequence, self-crossover bioequivalence study of amlodipine besylate orodisintegrating tablets (10 mg) in healthy subjects under fasting and fed 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 administration of the test preparation Amlodipine besylate orally disintegrating tablets (specification: 10 mg, produced by Shenzhen Xinlitai Pharmaceutical Co., Ltd., licensed by Guangdong Jincheng Jinsu Pharmaceutical Co., Ltd.) and the reference in the fasting and postprandial states. Preliminary pharmacokinetics of the preparation amlodipine besylate orally disintegrating tablets (trade name: ノルバスク®, specification: 10 mg, manufactured by ヴィアトリス薬 Co., Ltd., licensed by ヴィアトリス疬 Co., Ltd.) in healthy adult subjects The bioequivalence of the two formulations was evaluated for fasting and postprandial oral administration.
Secondary research purpose
To evaluate the safety of test preparation (T) amlodipine besylate orally disintegrating tablets and reference preparation (R) amlodipine besylate orally disintegrating tablets (ノルバスク®) administered to healthy subjects on an empty stomach and after a meal. sex.