MedTrace Logo

Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions

NCT04803734 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-18

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy

Interventions

DRUG

Albuterol Sulfate inhalation aerosol 108mcg per actuation

MDI, 2 puffs, single dose, fasting

DRUG

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

MDI, 2 puffs, single dose, fasting

Sponsors & Collaborators

  • Intech Biopharm Ltd.

    lead INDUSTRY

Principal Investigators

  • Wen-Kuei Chang, MD · Tamshui Mackay Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-19
Primary Completion
2021-05-10
Completion
2021-05-14

Countries

  • Taiwan

Study Locations

More Related Trials

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 NCT04803734 on ClinicalTrials.gov