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最高研发阶段批准上市 |
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首次获批日期2004-01-30 |
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最高研发阶段批准上市 |
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首次获批日期2000-08-24 |
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最高研发阶段批准上市 |
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首次获批日期1994-02-14 |
A Randomized, Single dose, Double blind, Double dummy, Placebo and Active Controlled, Crossover Design Study Using Bronchoprovocation to Evaluate the Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients with Stable Mild Asthma. - NIL
A Randomized, Single-dose, Double-blind, Double-dummy, Placebo and Active Controlled, Crossover Design Study Using Bronchoprovocation to Evaluate the Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma
The objective of this study is to evaluate the pharmacodynamic (PD) bioequivalence (BE) of albuterol inhalers, test formulation: Albuterol Sulfate HFA inhalation aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation and reference formulation: ProAir HFA (albuterol sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation manufactured by two different manufacturers using methacholine bronchoprovocation challenge test in patients with stable mild asthma.
A Randomized, Single-dose, Open-label, Two-way Crossover Pivotal Study to Assess the Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) in Healthy Volunteers Under Fasting Conditions
The primary objective of the study was to assess the bioequivalence between the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) and the reference product (Proair HFA [albuterol sulfate] Inhalation Aerosol 90mcg per actuation) under fasting conditions. Bioequivalence would be demonstrated if the 90% confidence interval for the ratios of geometric means for AUC(0-t), AUC(0-inf), and Cmax between test products and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.
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