NCT05292976

Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation

Multi-center, Randomized, Double Blind, Double Dummy, Placebo and Active Controlled, Crossover Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg in Stable Mild Asthma Patients

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Aurobindo Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg

Detailed description

To assess the pharmacodynamic bioequivalence of Albuterol Sulfate Inhalation Aerosol 0.09 mg base/ INH \[Aurobindo Pharma, USA, Inc\] compared to authorized generic drug Albuterol Sulfate HFA Inhalation Aerosol 0.09 mg per actuation \[Teva Pharmaceuticals USA, Inc\] in stable mild asthma patients, under Methacholine induced bronchoprovocation.

Conditions

• Bronchial Asthma

Interventions

Type	Name	Description
OTHER	Methacholine Chloride	Serial Methacholine dilutions
DRUG	Albuterol Sulfate HFA 0.09 mg (Reference)	One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols.
DRUG	Albuterol Sulfate HFA 0.18 mg (Reference)	One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.
DRUG	Albuterol Sulfate HFA 0.09 mg (Test)	One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols.
DRUG	Albuterol Sulfate HFA 0.18 mg (Test)	One actuation each from two different Test inhalation aerosols and one actuation each from two different placebo Reference inhalation aerosols.
DRUG	Placebo	One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2022-03-23
• Last updated: 2022-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study