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Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma
Sponsor: Intech Biopharm Ltd.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
20 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
148
Start Date
2022-08-15
Completion Date
2025-06
Last Updated
2025-02-17
Healthy Volunteers
No
Conditions
Interventions
Albuterol Sulfate inhalation aerosol 108 mcg per actuation
equal to albuterol 90 mcg/puff, MDI
Proair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation
equal to albuterol 90 mcg/puff, MDI
Proair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo
MDI
Albuterol Sulfate inhalation Placebo
MDI
Methacholine
Methacholine 100 mg/vial
Locations (12)
Dr. Jivraj Mehta Smarak Health Foundation
Ahmedabad, India
KLEs Dr Prabhakar Kore Hospital & MRC
Belagāve, India
NRS Medical College and Hospital
Kolkata, India
Medical College and Hospital
Kolkata, India
Aakash Healthcare Super Specialty Hospital
New Delhi, India
Pimpri Chinchwad Municipal Corporation Post Graduate Institute Yashwantrao Chavan Memorial Hospital
Pune, India
Kothrud Hospital
Pune, India
Ashirwad Hospital and Research Centre
Ulhasnagar, India
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Tamshui Mackay Memorial Hospital
New Taipei City, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan