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

• Status: Completed
• Trial end date: 2019-08-03
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharmaceutical Industries Limited
• Treatments: Albuterol; Procaterol

Criteria

Inclusion Criteria:

1. Men or non-pregnant women 18 to 65 years of age.

2. Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations.

3. Females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test

4. Ability to use inhalation aerosol correctly.

Exclusion Criteria:

1. Any clinically significant finding on physical exam in the opinion of the Investigator, would compromise subject's safety or data integrity.

2. Employees of the Investigator or research center or their immediate family members.

3. Previous participation in this study.

4. Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.