/ CompletedNot Applicable 头孢丙烯干混悬剂随机、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 dry suspension in Chinese healthy subjects
观察健康受试者空腹及餐后状态下单剂量口服受试制剂头孢丙烯干混悬剂（生产厂家：万邦德制药集团有限公司）后血药浓度的经时过程，估算相应的药代动力学参数；并以头孢丙烯干混悬剂（规格：250mg/5ml，持证商：Lupin LTD）为参比制剂，进行人体生物等效性正式试验，为该药注册申报和临床应用提供参考依据。
[Translation] The time course of blood drug concentration after a single oral dose of the test preparation cefprozil dry suspension (manufacturer: Wanbangde Pharmaceutical Group Co., Ltd.) in healthy subjects under fasting and postprandial states was observed, and the corresponding pharmacokinetic parameters were estimated. Cefprozil dry suspension (specification: 250mg/5ml, licensee: Lupin LTD) was used as the reference preparation for a formal human bioequivalence trial, which provided a reference for the drug registration application and clinical application.
/ CompletedNot Applicable 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.
/ CompletedNot Applicable 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.
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.
