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/NCT04803734
NCT04803734N/ACompleted
CompareCT.gov

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

Intech Biopharm Ltd.·interventional·Posted Mar 18, 2021·Updated Mar 18, 2024

In Brief

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

Detailed Summary

This study was designed to assess the bioequivalence between the test products (Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation) and the reference products (Proair HFA \[Albuterol Sulfate\] Inhalation Aerosol 90 mcg Per Actuation) in healthy volunteers under fasting conditions. The test product was considered bioequivalent to the reference product if the T/R ln-transformed AUC(0-t), AUC(0-inf), and Cmax were within 80.00-125.00% of those of the reference.

Study Details

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

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 18, 2021
Enrollment StartMar 19, 2021
Primary CompletionMay 10, 2021
Study CompletionMay 14, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.3 years ago

Interventions

Albuterol Sulfate inhalation aerosol 108mcg per actuationdrug

MDI, 2 puffs, single dose, fasting

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

MDI, 2 puffs, single dose, fasting