随机、开放、交叉对照设计,评价中国健康受试者在空腹及餐后状态下单次口服非布司他片后的生物等效性正式试验
[Translation] Randomized, open, cross-controlled design, to evaluate the bioequivalence of Chinese healthy subjects after a single oral administration of febuxostat tablets in the fasting and fed state
主要目的:以温岭市创新生物医药科技股份有限公司提供的非布司他片为受试制剂,按生物等效性试验的有关规定,与Teijin Pharma Limited 持证的非布司他片(商品名:Feburic®/菲布力®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
[Translation] Main purpose: Taking the febuxostat tablets provided by Wenling Innovative Biomedical Technology Co., Ltd. : Feburic®/Febuli®, reference preparation) to compare the absorption rate and degree of absorption in healthy humans, and investigate the human bioequivalence of the two preparations.
头孢丙烯片随机、开放、单剂量、两制剂、交叉设计在中国健康受试者中的生物等效性正式试验
[Translation] A randomized, open-label, single-dose, two-dose, cross-over design formal bioequivalence trial of cefprozil tablets in Chinese healthy subjects
以温岭市创新生物医药科技股份有限公司提供的头孢丙烯片为受试制剂,按生物等效性试验的有关规定,与Lupin Limited生产的头孢丙烯片(参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
[Translation] Taking Cefprozil Tablets provided by Wenling Innovative Biomedical Technology Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, the absorption in healthy human body was compared with that of Cefprozil Tablets produced by Lupine Limited (reference preparation) The speed and degree of absorption were used to investigate the human bioequivalence of the two preparations.
头孢克肟片随机、开放、单剂量、两制剂、交叉设计在中国健康受试者中的生物等效性正式试验
[Translation] Formal bioequivalence trial of cefixime tablets in a randomized, open-label, single-dose, two-dose, crossover design in healthy Chinese subjects
主要目的:以温岭市创新生物医药科技股份有限公司持证的头孢克肟片为受试制剂;并以Sanofi持证的头孢克肟片为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] Main purpose: Take cefixime tablets certified by Wenling Chuangxin Biomedical Technology Co., Ltd. as the test preparation; and take cefixime tablets certified by Sanofi as the reference preparation, to determine the relative bioavailability and bioequivalence of human body Sexual evaluation.
100 Clinical Results associated with Wenling City Innovation Biotechnology Co.,Ltd.
0 Patents (Medical) associated with Wenling City Innovation Biotechnology Co.,Ltd.
100 Deals associated with Wenling City Innovation Biotechnology Co.,Ltd.
100 Translational Medicine associated with Wenling City Innovation Biotechnology Co.,Ltd.