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] A randomized, open-label, crossover controlled study to evaluate the bioequivalence of a single oral dose of febuxostat tablets in healthy Chinese subjects 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: Using febuxostat tablets provided by Wenling Innovation Biopharmaceutical Technology Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, the absorption rate and degree of febuxostat tablets (trade name: Feburic®/Feibuli®, reference preparation) certified by Teijin Pharma Limited were compared in healthy humans, and the bioequivalence of the two preparations was investigated.
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, crossover 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] Cefprozil Tablets provided by Wenling Innovation Biotechnology Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, the absorption rate and degree of the two preparations in healthy humans were compared with those of Cefprozil Tablets (reference preparation) produced by Lupin Limited to investigate the bioequivalence of the two preparations in humans.
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] A randomized, open-label, single-dose, two-dose, crossover design formal bioequivalence trial of cefixime tablets in Chinese healthy 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: To evaluate the relative bioavailability and bioequivalence in humans using the cefixime tablets certified by Wenling Innovation Biotechnology Co., Ltd. as the test preparation and the cefixime tablets certified by Sanofi as the reference preparation.
100 Clinical Results associated with Wenling City Innovation Biotechnology Co., Ltd.
0 Patents (Medical) associated with Wenling City Innovation Biotechnology Co., Ltd.
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100 Translational Medicine associated with Wenling City Innovation Biotechnology Co., Ltd.