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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT03528577

Run by

Sun Pharmaceutical Industries Limited

People needed

128

Starts

2018-09-22

Expected to finish

2019-08-03

Last updated by the study team

2021-01-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• SPARC Site 02 — Miami Lakes, Florida, United States
• SPARC site 01 — Bethesda, Maryland, United States
• SPARC Site 04 — St Louis, Missouri, United States
• SPARC Site 06 — Gastonia, North Carolina, United States
• SPARC Site 05 — Edmond, Oklahoma, United States
• SPARC Site 07 — Warwick, Rhode Island, United States
• SPARC Site 08 — Boerne, Texas, United States
• SPARC Site 03 — Waco, Texas, United States

Full record on ClinicalTrials.gov

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