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

NCT05292976 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-05-20

No results posted yet for this study

Summary

Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg

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.

Sponsors & Collaborators

  • Aurobindo Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Joseph Marialouis, MD · Aurobindo Pharma Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2022-10-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05292976 on ClinicalTrials.gov