[Translation] Bioequivalence study of vortioxetine hydrobromide tablets in human subjects
主要研究目的:以持证商为TAKEDA PHARMACEUTICALS USA INC的氢溴酸伏硫西汀片(规格:20mg,商品名:TRINTELLIX)为参比制剂,以合肥创新医药技术有限公司提供的氢溴酸伏硫西汀片(规格:20mg)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:评价口服受试制剂氢溴酸伏硫西汀片(规格:20mg)和参比制剂氢溴酸伏硫西汀片( 规格:20mg,商品名:TRINTELLIX)在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the vortioxetine hydrobromide tablets (specification: 20 mg, trade name: TRINTELLIX) of the licensee TAKEDA PHARMACEUTICALS USA INC as the reference preparation and the vortioxetine hydrobromide tablets (specification: 20 mg) provided by Hefei Innovation Pharmaceutical Technology Co., Ltd. as the 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 postprandial states in healthy Chinese subjects.
Secondary purpose of the study: To evaluate the safety of the oral test preparation vortioxetine hydrobromide tablets (specification: 20 mg) and the reference preparation vortioxetine hydrobromide tablets (specification: 20 mg, trade name: TRINTELLIX) in healthy Chinese subjects.
[Translation] Preliminary study on bioequivalence of vortioxetine hydrobromide tablets in human subjects
主要研究目的:按有关生物等效性试验的规定,选择TAKEDAPHARMACEUTICALS USA的氢溴酸伏硫西汀片(规格:20mg,商品名:TRINTELLIX)为参比制剂,对合肥创新医药技术有限公司生产的受试制剂氢溴酸伏硫西汀片(规格:20mg)进行空腹和餐后给药人体生物等效性预试验,比较受试制剂和参比制剂中药物的吸收速度和吸收程度,考察关键药动学参数的个体内变异度,为正式试验样本量确定及试验方案优化提供依据。
次要研究目的:评价口服受试制剂氢溴酸伏硫西汀片(规格:20mg)和参比制剂氢溴酸伏硫西汀片( 规格:20mg,商品名:TRINTELLIX)在中国健康受试者中的安全性。
[Translation] Main purpose of the study: According to the relevant provisions of bioequivalence tests, vortioxetine hydrobromide tablets (specification: 20 mg, trade name: TRINTELLIX) produced by TAKEDA PHARMACEUTICALS USA were selected as the reference preparation. The test preparation vortioxetine hydrobromide tablets (specification: 20 mg) produced by Hefei Innovation Pharmaceutical Technology Co., Ltd. were used for fasting and postprandial human bioequivalence preliminary tests. The absorption rate and degree of the drug in the test preparation and the reference preparation were compared, and the intra-individual variability of key pharmacokinetic parameters was investigated to provide a basis for the determination of the sample size of the formal test and the optimization of the test plan.
Secondary purpose of the study: To evaluate the safety of the oral test preparation vortioxetine hydrobromide tablets (specification: 20 mg) and the reference preparation vortioxetine hydrobromide tablets (specification: 20 mg, trade name: TRINTELLIX) in healthy Chinese subjects.
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.
100 Clinical Results associated with Hefei Chuangxin Medicine Technology Co., Ltd.
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