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Originator Org.- |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.IT |
First Approval Date01 Oct 1988 |
Bronchodilator Effect of Oral Doxofylline and Procaterol in Chronic Obstructive Pulmonary Disease : A Randomized Crossover Study
The goal of this clinical trial is to determine if doxofylline and procaterol are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.
The main questions it aims to answer are:
Does doxofylline demonstrate a comparable bronchodilator effect to procaterol in COPD participants?
What medical problems do participants experience when taking doxofylline and procaterol?"
多索茶碱片(0.4 g)在餐后状态下健康人体生物等效性研究
[Translation] Bioequivalence study of doxofylline tablets (0.4 g) in healthy humans under postprandial conditions
主要目的:
本研究以福安药业集团宁波天衡制药有限公司研发的多索茶碱片(规格:0.4 g)为受试制剂,按生物等效性研究的有关规定,以原研厂家ABC FARMACEUTICI S.P.A.持有的多索茶碱片(规格:400 mg,商品名:ANSIMAR®)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:
观察受试制剂多索茶碱片和参比制剂多索茶碱片(ANSIMAR®)在健康受试者中的安全性。
[Translation] main purpose:
This study uses doxofylline tablets (specification: 0.4 g) developed by Fuan Pharmaceutical Group Ningbo Tianheng Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations on bioequivalence studies, the original research manufacturer ABC FARMACEUTICI S.P.A. Doxofylline tablets (specification: 400 mg, trade name: ANSIMAR®) are reference preparations to evaluate the bioequivalence of the test preparation and the reference preparation after administration in the postprandial state.
Secondary purpose:
Observe the safety of the test preparation Doxofylline Tablets and the reference preparation Doxofylline Tablets (ANSIMAR®) in healthy subjects.
[Translation] Study on the bioequivalence of doxofylline tablets in healthy human subjects under fasting state
主要目的:
本研究以福安药业集团宁波天衡制药有限公司研发的多索茶碱片(规格:0.4 g)为受试制剂,按生物等效性研究的有关规定,以原研厂家ABC FARMACEUTICI S.P.A.持有的多索茶碱片(规格:400 mg,商品名:ANSIMAR®)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:
观察受试制剂多索茶碱片和参比制剂多索茶碱片(ANSIMAR®)在健康受试者中的安全性。
[Translation] main purpose:
This study uses doxofylline tablets (specification: 0.4 g) developed by Fuan Pharmaceutical Group Ningbo Tianheng Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations on bioequivalence studies, the original research manufacturer ABC FARMACEUTICI S.P.A. Doxofylline tablets (specification: 400 mg, trade name: ANSIMAR®) are reference preparations to evaluate the bioequivalence of the test preparation and the reference preparation after administration in the fasting state.
Secondary purpose:
Observe the safety of the test preparation Doxofylline Tablets and the reference preparation Doxofylline Tablets (ANSIMAR®) in healthy subjects.
100 Clinical Results associated with PDE x A2aR x PDE2A
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