比索洛尔氨氯地平片在空腹和餐后给药条件下随机、开放、单剂量、两周期双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-period double-crossover bioequivalence study of bisoprolol and amlodipine tablets under fasting and fed conditions
主要研究目的:以持证商Merck Kft,Egis Pharmaceuticals PLC生产的比索洛尔氨氯地平片(商品名:康忻安®、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)为参比制剂,以安徽博诺美科生物医药有限公司提供的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)为受试制剂,采用随机、开放、单剂量、两周期双交叉设计,评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要研究目的:评价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)和参比制剂(商品名:康忻安®、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)在中国健康受试者中的安全性。
[Translation] Main research purpose: Using bisoprolol amlodipine tablets (trade name: Kangxinan®, specifications: bisoprolol fumarate 5mg and amlodipine besylate (calculated as amlodipine) 5mg) produced by licensed manufacturer Merck Kft, Egis Pharmaceuticals PLC as reference preparation, and bisoprolol amlodipine tablets (specifications: bisoprolol fumarate 5mg and amlodipine besylate (calculated as amlodipine) 5mg) provided by Anhui Bonomeco Biopharmaceutical Co., Ltd. as test preparation, a randomized, open, single-dose, two-period double crossover design was used to evaluate the bioequivalence of the two preparations in fasting and fed states in healthy Chinese subjects.
Secondary study objective: To evaluate the safety of the oral test preparation bisoprolol amlodipine tablets (specifications: bisoprolol fumarate 5 mg and amlodipine besylate (calculated as amlodipine) 5 mg) and the reference preparation (trade name: Kangxinan®, specifications: bisoprolol fumarate 5 mg and amlodipine besylate (calculated as amlodipine) 5 mg) in healthy Chinese subjects.
利伐沙班片在空腹和餐后给药条件下随机、开放、单剂量、四周期、完全重复交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, four-period, fully repeated crossover bioequivalence study of rivaroxaban tablets under fasting and fed conditions
主要研究目的:以Bayer AG生产的利伐沙班片(规格:2.5mg,商品名:Xarelto)为参比制剂,以安徽博诺美科生物医药有限公司提供的利伐沙班片(规格2.5mg)为受试制剂,采用随机、开放、单剂量、四周期、完全重复交叉设计,评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要研究目的:观察健康受试者口服受试制剂利伐沙班片(规格2.5mg)和参比制剂利伐沙班片(规格:2.5mg,商品名:Xarelto)的安全性。
[Translation] The main purpose of the study was to use rivaroxaban tablets (specification: 2.5 mg, trade name: Xarelto) produced by Bayer AG as the reference preparation and rivaroxaban tablets (specification: 2.5 mg) provided by Anhui Bonomei Biopharmaceutical Co., Ltd. as the test preparation. A randomized, open, single-dose, four-period, completely repeated crossover design was used to evaluate the bioequivalence of the two preparations in fasting and postprandial states in healthy Chinese subjects.
Secondary purpose of the study was to observe the safety of oral administration of the test preparation rivaroxaban tablets (specification: 2.5 mg) and the reference preparation rivaroxaban tablets (specification: 2.5 mg, trade name: Xarelto) in healthy subjects.
100 Clinical Results associated with Anhui Bonomic Biomedical Co., Ltd.
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100 Deals associated with Anhui Bonomic Biomedical Co., Ltd.
100 Translational Medicine associated with Anhui Bonomic Biomedical Co., Ltd.