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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date31 May 1983 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date08 Feb 1967 |
非布司他片在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床试验。
[Translation] Human bioequivalence clinical trial of single-dose febuxostat tablets in Chinese healthy people under fasting and postprandial conditions.
主要目的:以持证商为Teijin Pharma Limited.的非布司他片(商品名:Feburic(菲布力),规格:40mg)为参比制剂,以陕西西岳制药有限公司研发的非布司他片(40mg)为受试制剂,通过单中心、随机、开放、单次给药、两制剂、两周期、两序列、交叉设计的临床试验来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。
次要目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main purpose: Use the febuxostat tablets (trade name: Feburic, specification: 40mg) licensed by Teijin Pharma Limited. as the reference preparation, and use the febuxostat tablets developed by Shaanxi Xiyue Pharmaceutical Co., Ltd. Tablets (40 mg) are test preparations. A single-center, randomized, open-label, single-dose, two-preparation, two-cycle, two-sequence, crossover design clinical trial was conducted to evaluate the efficacy of the two preparations in Chinese healthy subjects on an empty stomach and Bioequivalence in the postprandial state.
Secondary purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.
100 Clinical Results associated with Shaanxi Xiyue Pharmaceutical Co Ltd
0 Patents (Medical) associated with Shaanxi Xiyue Pharmaceutical Co Ltd
100 Deals associated with Shaanxi Xiyue Pharmaceutical Co Ltd
100 Translational Medicine associated with Shaanxi Xiyue Pharmaceutical Co Ltd