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MechanismDHODH inhibitors |
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Drug Highest PhasePhase 1 |
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[Translation] Study on Bioequivalence of Teriflunomide Tablets in Human
采用单中心、随机、开放、单次给药、平行试验设计比较空腹和餐后给药条件下,苏州长
征-欣凯制药有限公司提供的特立氟胺片(规格:14 mg)与 Sanofi Aventis U.S. Inc 持证的特立
氟胺片(规格:14 mg,商品名:Aubagio®(奥巴捷®))在中国健康人群吸收程度和吸收速度
的差异,并评价苏州长征-欣凯制药有限公司提供的特立氟胺片的安全性。
[Translation] A single-center, randomized, open, single-dose, parallel trial design was used to compare fasting and postprandial drug administration conditions.
Teriflunomide tablets (specification: 14 mg) provided by Zheng-Xinkai Pharmaceutical Co., Ltd. and Teriflunomide tablets licensed by Sanofi Aventis U.S. Inc
Fluoramide tablets (specification: 14 mg, trade name: Aubagio®) absorption degree and speed in Chinese healthy people
and evaluate the safety of teriflunomide tablets provided by Suzhou Changzheng-Xinkai Pharmaceutical Co., Ltd.
[Translation] Human Bioequivalence Study of Hydroxychloroquine Sulfate Tablets
以苏州长征欣凯制药有限公司生产的硫酸羟氯喹片(规格:200 mg)为受试制剂,以Aventis Pharma Limited持证的硫酸羟氯喹片(规格:0.2 g,商品名:PLAQUENIL®)为参比制剂,通过单中心、随机、开放、单次给药、单周期平行试验设计临床研究来评价两种制剂空腹及餐后状态下的人体生物等效性。
[Translation] The hydroxychloroquine sulfate tablet (specification: 200 mg) produced by Suzhou Changzheng Xinkai Pharmaceutical Co., Ltd. was used as the test preparation, and the hydroxychloroquine sulfate tablet (specification: 0.2 g, trade name: PLAQUENIL®) licensed by Aventis Pharma Limited was used as the reference. Compared with the preparations, the human bioequivalence of the two preparations in fasting and postprandial states was evaluated through a single-center, randomized, open, single-dose, single-cycle parallel trial design clinical study.
替诺福韦十八烷氧乙酯在健康受试者中单次给药的安全性和药代动力学Ia期临床研究
[Translation] Phase Ia clinical study of safety and pharmacokinetics of single-dose tenofovir stearyloxyethyl in healthy subjects
1.评价替诺福韦十八烷氧乙酯在健康受试者中单次给药的安全性; 2.评价替诺福韦十八烷氧乙酯在健康受试者中单次给药的药代动力学特征。
[Translation] 1. To evaluate the safety of a single dose of tenofovir stearyloxyethyl in healthy subjects; 2. To evaluate a single dose of tenofovir stearyloxyethyl in healthy subjects pharmacokinetic characteristics.
100 Clinical Results associated with Suzhou Changzheng Cinkate Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Suzhou Changzheng Cinkate Pharmaceutical Co., Ltd.
100 Deals associated with Suzhou Changzheng Cinkate Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Suzhou Changzheng Cinkate Pharmaceutical Co., Ltd.