A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)

Study Overview
=================
Brief Summary
-----------------
To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma

Official Title
-----------------
A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Four-Sequence, Four-Treatment, Placebo and Active Controlled, Comparative, Multiple-Center, Crossover-Design, Bronchoprovocation Study to Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (Albuterol Sulfate) Inhalation Aerosol, eq 90 mcg Base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Zero-dose
* Drug: 90 mcg of PROAIR® HFA
* Drug: 180 mcg of 90 mcg of PROAIR® HFA
* Drug: 90 mcg of albuterol sulfate inhalation aerosol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or non-pregnant women 18 to 65 years of age. Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations. Females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test Ability to use inhalation aerosol correctly. Exclusion Criteria: Any clinically significant finding on physical exam in the opinion of the Investigator, would compromise subject's safety or data integrity. Employees of the Investigator or research center or their immediate family members. Previous participation in this study. Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Albuterol Sulfate Inhalation Aerosol, eq 90 mcg | Drug: Zero-dose<br>* Treatment A<br>Drug: 90 mcg of PROAIR® HFA<br>* Treatment B<br>Drug: 180 mcg of 90 mcg of PROAIR® HFA<br>* Treatment C<br>Drug: 90 mcg of albuterol sulfate inhalation aerosol<br>* Treatment D<br>|
| Active Comparator: Reference<br>PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg | Drug: Zero-dose<br>* Treatment A<br>Drug: 90 mcg of PROAIR® HFA<br>* Treatment B<br>Drug: 180 mcg of 90 mcg of PROAIR® HFA<br>* Treatment C<br>Drug: 90 mcg of albuterol sulfate inhalation aerosol<br>* Treatment D<br>|
| Placebo Comparator: Test Placebo<br>Placebo for Albuterol Sulfate Inhalation Aerosol | Drug: Zero-dose<br>* Treatment A<br>Drug: 90 mcg of PROAIR® HFA<br>* Treatment B<br>Drug: 180 mcg of 90 mcg of PROAIR® HFA<br>* Treatment C<br>Drug: 90 mcg of albuterol sulfate inhalation aerosol<br>* Treatment D<br>|
| Placebo Comparator: Reference Placebo<br>Placebo for Albuterol Sulfate Inhalation Aerosol | Drug: Zero-dose<br>* Treatment A<br>Drug: 90 mcg of PROAIR® HFA<br>* Treatment B<br>Drug: 180 mcg of 90 mcg of PROAIR® HFA<br>* Treatment C<br>Drug: 90 mcg of albuterol sulfate inhalation aerosol<br>* Treatment D<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic Endpoint Post-dose PC20 | The primary pharmacodynamic endpoint is the post-dose PC20, which is the provocative concentration of methacholine challenge agent required to reduce the forced expiry volume in one second (FEV1) by 20%, following the administration of different doses of albuterol (or placebo) by inhalation. Primary analysis group -pharmacodynamic population. | Approximately 15 minutes after last inhalation of study product |