CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Albuterol Sulfate Inhalation Aerosol 108mcg per actuation +1 moredrug
Likely dose
Albuterol Sulfate Inhalation Aerosol 108mcg per actuationfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05300087
NCT05300087N/ACompleted
CompareCT.gov

A Randomized, Single-dose, Open-label, Two-way Crossover Pivotal Study to Assess the Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation (MDI, eq. to Albuterol 90mcg/Puff) in Healthy Volunteers Under Fasting Conditions

Intech Biopharm Ltd.·interventional·Posted Mar 29, 2022·Updated Mar 18, 2024

In Brief

A clinical study evaluating Albuterol Sulfate Inhalation Aerosol 108mcg per actuation and Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation for Healthy. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The primary objective of the study was to assess the bioequivalence between the test product (Albuterol Sulfate inhalation aerosol 108mcg per actuation) and the reference product (Proair HFA \[albuterol sulfate\] Inhalation Aerosol 90mcg per actuation) under fasting conditions. Bioequivalence would be demonstrated if the 90% confidence interval for the ratios of geometric means for AUC(0-t), AUC(0-inf), and Cmax between test products and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesTaiwan
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 29, 2022
Enrollment StartFeb 24, 2022
Primary CompletionApr 25, 2022
Study CompletionApr 26, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.3 years ago

Interventions

Albuterol Sulfate Inhalation Aerosol 108mcg per actuationdrug

MDI, 2 puffs, single dose, fasting

Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuationdrug

MDI, 2 puffs, single dose, fasting