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

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

April 30, 2022

Primary Completion Date

October 31, 2022

Study Completion Date

December 31, 2022

Conditions
Bronchial Asthma
Interventions
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.

Trial Locations (1)

95117

Investigational site #1, San Jose

Sponsors
All Listed Sponsors
lead

Aurobindo Pharma Ltd

INDUSTRY

NCT05292976 - Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation | Biotech Hunter | Biotech Hunter