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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 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.
/ CompletedNot Applicable [Translation] Bioequivalence study of dapoxetine hydrochloride tablets in humans
采用单中心、随机、开放、双周期交叉、单剂量给药设计,比较空腹和餐后给药条件下,苏州特瑞药业股份有限公司生产的盐酸达泊西汀片(规格:30 mg)与Berlin-Chemie AG持证的盐酸达泊西汀片(商品名:Priligy®/必利劲®,规格:30 mg)在中国健康人群中吸收程度和吸收速度的差异,评价空腹和餐后状态下口服两种制剂的生物等效性,并评价苏州特瑞药业股份有限公司生产的盐酸达泊西汀片(规格:30 mg)的安全性。
[Translation] A single-center, randomized, open, two-period crossover, single-dose design was used to compare the differences in absorption extent and rate between dapoxetine hydrochloride tablets (specification: 30 mg) produced by Suzhou Terui Pharmaceutical Co., Ltd. and dapoxetine hydrochloride tablets (trade name: Priligy®, specification: 30 mg) certified by Berlin-Chemie AG in healthy Chinese people under fasting and fed conditions, to evaluate the bioequivalence of the two oral preparations under fasting and fed conditions, and to evaluate the safety of dapoxetine hydrochloride tablets (specification: 30 mg) produced by Suzhou Terui Pharmaceutical Co., Ltd.
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.