[Translation] A single oral dose of bisoprolol and amlodipine tablets in healthy subjects under fasting and postprandial conditions
Bioequivalence of a randomized, open-label, two-agent, two-period, two-sequence, double-crossover design
sexual experiment
主要研究目的
研究空腹和餐后状态下单次口服受试制剂比索洛尔氨氯地平片(规格:
富马酸比索洛尔 5mg 与苯磺酸氨氯地平(按氨氯地平计)5mg),裕松源药
业有限公司生产,杭州和泽坤元药业有限公司提供)与参比制剂比索洛尔氨
氯地平片(规格:富马酸比索洛尔 5mg 与苯磺酸氨氯地平(按氨氯地平计)
5mg,持证商:Merck Kft)在健康成年受试者体内的药代动力学,评价两制
剂生物等效性。
次要研究目的
评价健康受试者空腹和餐后状态下单次口服受试制剂(T)比索洛尔氨
氯地平片和参比制剂(R)比索洛尔氨氯地平片(康忻安®)后的安全性。
[Translation] Main research purpose
Study the single oral administration of the test preparation Bisoprolol Amlodipine Tablets (Specification:
Bisoprolol fumarate 5mg and amlodipine besylate (calculated as amlodipine) 5mg), Yusongyuan Pharmaceutical
Co., Ltd. and provided by Hangzhou Heze Kunyuan Pharmaceutical Co., Ltd.) and the reference preparation bisoprolol ammonia
Clodipine tablets (specification: bisoprolol fumarate 5mg and amlodipine besylate (calculated as amlodipine)
5mg, Licensee: Merck Kft) Pharmacokinetics in Healthy Adult Subjects, Evaluation of Two Systems
Agent bioequivalence.
Secondary research purpose
Evaluation of single oral doses of test formulation (T) bisoprolol in healthy subjects in the fasting and postprandial states
Safety of clodipine tablets and reference preparation (R) after bisoprolol and amlodipine tablets (Kangxinan®).