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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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Inactive Indication- |
Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ 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.
/ CompletedNot Applicable 孟鲁司特钠片(10 mg)在餐后状态下健康人体生物等效性研究
[Translation] Bioequivalence study of montelukast sodium tablets (10 mg) in healthy human subjects after meals
主要目的: 本研究以江苏万高药业股份有限公司生产并持有的孟鲁司特钠片(规格:10 mg)为受试制剂,按生物等效性研究的有关规定,以N.V.Organon持有的孟鲁司特钠片(规格:10 mg,商品名:Singulair®/顺尔宁®)为参比制剂,评估受试制剂和参比制剂在餐后状态下给药后的生物等效性。 次要目的: 观察受试制剂孟鲁司特钠片和参比制剂孟鲁司特钠片(商品名:Singulair®/顺尔宁®)在健康受试者中的安全性。
[Translation] Primary Objective: This study used montelukast sodium tablets (10 mg) manufactured and owned by Jiangsu Wango Pharmaceutical Co., Ltd. as the test formulation, and montelukast sodium tablets (10 mg, trade name: Singulair®) owned by N.V. Organon as the reference formulation, in accordance with the relevant regulations for bioequivalence studies, to evaluate the bioequivalence of the test and reference formulations after administration under postprandial conditions. Secondary Objective: To observe the safety of the test and reference formulations, montelukast sodium tablets (trade name: Singulair®), in healthy subjects.
/ CompletedNot Applicable 孟鲁司特钠片(10 mg)在空腹状态下健康人体生物等效性研究
[Translation] Bioequivalence study of montelukast sodium tablets (10 mg) in healthy volunteers in the fasting state
主要目的:
本研究以江苏万高药业股份有限公司生产并持有的孟鲁司特钠片(规格:10 mg)为受试制剂,按生物等效性研究的有关规定,以N.V.Organon持有的孟鲁司特钠片(规格:10 mg,商品名:Singulair®/顺尔宁®)为参比制剂,评估受试制剂和参比制剂在空腹状态下给药后的生物等效性。
次要目的:
观察受试制剂孟鲁司特钠片和参比制剂孟鲁司特钠片(商品名:Singulair®/顺尔宁®)在健康受试者中的安全性。
[Translation] Primary Objective:
This study used montelukast sodium tablets (10 mg) manufactured and owned by Jiangsu Wangao Pharmaceutical Co., Ltd. as the test formulation. Montelukast sodium tablets (10 mg, trade name: Singulair®/Singulair®) manufactured by N.V. Organon served as the reference formulation in accordance with relevant bioequivalence study regulations. The study evaluated the bioequivalence of the test and reference formulations after administration in the fasting state.
Secondary Objective:
To observe the safety of the test and reference formulations, montelukast sodium tablets (trade name: Singulair®/Singulair®), in healthy volunteers.
100 Clinical Results associated with Jiangsu Vanguard Pharmaceutical Co.,Ltd.
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