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MechanismPDE5A inhibitors |
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Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Active, not recruitingNot Applicable [Translation] Bioequivalence study of fenofibrate choline sustained-release capsules
主要目的:本研究以苏州特瑞药业股份有限公司研制的非诺贝特酸胆碱缓释胶囊为受试制剂,原研厂家Abbvie Inc持证、Fournier Laboratories Ireland Limited生产的非诺贝特酸胆碱缓释胶囊(商品名:Trilipix)为参比制剂,评估受试制剂和参比制剂在空腹和餐后给药状态下是否具有生物等效性。次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: This study used fenofibric acid choline sustained-release capsules developed by Suzhou Tri-Ray Pharmaceutical Co., Ltd. as the test preparation and fenofibric acid choline sustained-release capsules (trade name: Trilipix) produced by Fournier Laboratories Ireland Limited, the original manufacturer Abbvie Inc, as the reference preparation to evaluate whether the test preparation and the reference preparation are bioequivalent under fasting and postprandial administration. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
/ Active, not recruitingPhase 1 司美格鲁肽注射液在健康成人受试者中的药代动力学特征比较的随机、开放、平行入组的I期临床研究
[Translation] A randomized, open-label, parallel-group phase I clinical study comparing the pharmacokinetic characteristics of semaglutide injection in healthy adult subjects
比较单次皮下注射试验药物司美格鲁肽注射液(规格:1.5mL:1mg)与对照药物司美格鲁肽注射液(商品名:Wegovy®,规格:1.5mL:1mg)后在中国健康成人受试者体内的药代动力学特征和安全性。
[Translation] To compare the pharmacokinetic characteristics and safety of the investigational drug semaglutide injection (specification: 1.5mL:1mg) and the control drug semaglutide injection (trade name: Wegovy®, specification: 1.5mL:1mg) in healthy Chinese adult subjects after a single subcutaneous injection.
/ CompletedNot Applicable [Translation] Bioequivalence study of aluminum magnesium aspirin tablets (Ⅱ)
本研究以苏州特瑞药业股份有限公司研制的铝镁匹林片(Ⅱ)为受试制剂,原研厂家持证商Lion Corporation的铝镁匹林片(Ⅱ)(商品名:BUFFERIN Combination Tab. A81)为参比制剂,评估受试制剂和参比制剂在空腹和餐后给药状态下是否具有生物等效性。观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] This study used BUFFERIN Combination Tab. A81 developed by Suzhou Terui Pharmaceutical Co., Ltd. as the test preparation and BUFFERIN Combination Tab. A81 developed by Lion Corporation as the reference preparation to evaluate whether the test preparation and the reference preparation are bioequivalent under fasting and postprandial administration conditions. The safety of the test preparation and the reference preparation in healthy subjects was observed.
100 Clinical Results associated with Suzhou Thery Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Suzhou Thery Pharmaceutical Co., Ltd.
100 Deals associated with Suzhou Thery Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Suzhou Thery Pharmaceutical Co., Ltd.