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MechanismDHODH inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date10 Sep 1998 |
Target- |
Mechanism- |
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Originator Org.- |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
[Translation] Study on the bioequivalence of teriflunomide tablets in healthy volunteers
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 the differences in the degree and rate of absorption of teriflunomide tablets (specification: 14 mg) provided by Suzhou Changzheng-Xinkai Pharmaceutical Co., Ltd. and teriflunomide tablets (specification: 14 mg, trade name: Aubagio®) licensed by Sanofi Aventis U.S. Inc. in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of teriflunomide tablets provided by Suzhou Changzheng-Xinkai Pharmaceutical Co., Ltd.
[Translation] Study on the bioequivalence of hydroxychloroquine sulfate tablets in human body
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] Hydroxychloroquine sulfate tablets (specification: 200 mg) produced by Suzhou Changzheng Xinkai Pharmaceutical Co., Ltd. were used as the test preparation, and hydroxychloroquine sulfate tablets (specification: 0.2 g, trade name: PLAQUENIL®) certified by Aventis Pharma Limited were used as the reference preparation. A single-center, randomized, open, single-dose, single-period parallel trial design clinical study was conducted to evaluate the bioequivalence of the two preparations in humans under fasting and fed conditions.
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 on the safety and pharmacokinetics of single-dose tenofovir disoproxil fumarate 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 disoproxil fumarate in healthy subjects. 2. To evaluate the pharmacokinetic characteristics of a single dose of tenofovir disoproxil fumarate in healthy subjects.
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.