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



Status:Active, not recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:2/17/2019
Start Date:September 22, 2018
End Date:April 2019

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Trial Summary
Trial Overview
Inclusion Criteria

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

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


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.
We found this trial at
8
sites
SPARC Site 02
Miami Lakes, Florida 33014
Phone: 305-558-7559
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SPARC site 01
Bethesda, Maryland 20814
Phone: 301-907-3476
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Bethesda, MD
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SPARC Site 08
Boerne, Texas 78006
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Boerne, TX
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SPARC Site 05
Edmond, Oklahoma 73034
Phone: 405-285-6811
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Edmond, OK
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SPARC Site 06
Gastonia, North Carolina 28054
Phone: 704-675-7144
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Gastonia, NC
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SPARC SIte 04
Saint Louis, Missouri 63141
Phone: 314-514-8509
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Saint Louis, MO
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SPARC Site 03
Waco, Texas 76712
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Waco, TX
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SPARC Site 07
Warwick, Rhode Island 02886
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Warwick, RI
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