比索洛尔氨氯地平片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of bisoprolol and amlodipine tablets in humans under fasting and fed conditions
考察空腹及餐后条件下,健康受试者单次口服由广东方盛健盟药业有限公司提供的比索洛尔氨氯地平片【受试制剂,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】与相同条件下单次口服由Merck Kft持证的比索洛尔氨氯地平片【参比制剂,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】的药动学特征,评价两制剂间的生物等效性及安全性,为受试制剂的注册申请提供依据。
[Translation] To investigate the pharmacokinetic characteristics of a single oral administration of bisoprolol amlodipine tablets [test preparation, specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)] provided by Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd. in healthy subjects under fasting and postprandial conditions and a single oral administration of bisoprolol amlodipine tablets [reference preparation, specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine)] certified by Merck Kft under the same conditions, evaluate the bioequivalence and safety of the two preparations, and provide a basis for the registration application of the test preparation.
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