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MechanismCYP17A1 inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date28 Apr 2011 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date29 Dec 2005 |
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MechanismHIF-1α inhibitors |
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Inactive Indication- |
Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ RecruitingNot Applicable [Translation] Bioequivalence study of Sulindac tablets in healthy human subjects
主要目的:
本研究以江苏万高药业股份有限公司研发的舒林酸片(规格:200 mg)为受
试制剂,按生物等效性研究的有关规定,以Watson Pharma Private Ltd.生产的舒
林酸片(规格:200 mg ,商品名:Sulindac®)为参比制剂,评估受试制剂和参
比制剂在空腹/餐后条件下给药后的生物等效性。
次要目的:
观察受试制剂舒林酸片和参比制剂舒林酸片(Sulindac®)在健康试验参与
者中的安全性。
[Translation] Primary Objective: This study used sulindac tablets (200 mg) developed by Jiangsu Wango Pharmaceutical Co., Ltd. as the test formulation, and sulindac tablets (200 mg, trade name: Sulindac®) manufactured by Watson Pharma Private Ltd. as the reference formulation, in accordance with relevant regulations for bioequivalence studies, to evaluate the bioequivalence of the test and reference formulations under fasting/postprandial conditions.
Secondary Objective: To observe the safety of the test and reference formulations, sulindac tablets (Sulindac®), in healthy participants.
/ TerminatedNot Applicable [Translation] Atorvastatin calcium tablets postprandial bioequivalence study
"主要研究目的
评价中国健康成年研究参与者餐后条件下单次单剂量口服阿托伐他汀钙片受试制剂(规格:20mg,申办者:江苏万高药业股份有限公司)和参比制剂(商品名:立普妥®,规格:20mg,持证商:辉瑞制药有限公司)后的药代动力学特点和生物等效性。
次要研究目的
评价阿托伐他汀钙片受试制剂(规格:20mg)和参比制剂(商品名:立普妥®,规格:20mg)在中国健康成年研究参与者中的安全性。"
[Translation] Primary Study Objective: To evaluate the pharmacokinetic characteristics and bioequivalence of a single oral dose of atorvastatin calcium tablets (20 mg, sponsor: Jiangsu Wango Pharmaceutical Co., Ltd.) and the reference formulation (Lipitor®, 20 mg, licensee: Pfizer Inc.) after a meal in healthy adult participants in China.
Secondary Study Objective: To evaluate the safety of atorvastatin calcium tablets (20 mg, test formulation: 20 mg) and the reference formulation (Lipitor®, 20 mg) in healthy adult participants in China.
/ CompletedNot Applicable [Translation] Tadalafil tablets postprandial bioequivalence study
主要研究目的
评价中国健康成年男性受试者餐后条件下单次单剂量口服他达拉非片受试制剂(规格:20mg,申办者:江苏万高药业股份有限公司)和参比制剂(商品名:希爱力®,规格:20mg,持证商:A.Menarini Gmbh)后的药代动力学特点和生物等效性。
次要研究目的
研究他达拉非片受试制剂(规格:20mg)和参比制剂(商品名:希爱力®,规格:20mg)在中国健康成年男性受试者中的安全性。
[Translation] Primary Study Objective: To evaluate the pharmacokinetic characteristics and bioequivalence of a single oral dose of tadalafil tablets (test formulation, strength: 20 mg, sponsor: Jiangsu Wango Pharmaceutical Co., Ltd.) and reference formulation (trade name: Cialis®, strength: 20 mg, licensee: A. Menarini GmbH) after a meal in healthy adult male subjects in China.
Secondary Study Objective: To investigate the safety of tadalafil tablets (test formulation, strength: 20 mg) and reference formulation (trade name: Cialis®, strength: 20 mg) in healthy adult male subjects in China.
100 Clinical Results associated with Jiangsu Vanguard Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jiangsu Vanguard Pharmaceutical Co., Ltd.
100 Deals associated with Jiangsu Vanguard Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangsu Vanguard Pharmaceutical Co., Ltd.