Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma
Recruiting
N/A
Interventional Study
Mild Asthma
At a Glance
- Age
- 20 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 148 (estimated)
- Sponsor
- Intech Biopharm Ltd. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male, non-pregnant and non-lactating female subjects (20-65 years of age, inclusive).
2. A clinical diagnosis of mild asthma with historical documentation of the asthma diagnosis according to either: (1) the National Asthma Education and Prevention Program (NAEPP) guidelines …
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