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

NCT05300087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-18

Study results available
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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%.

Conditions

  • Healthy

Interventions

DRUG

Albuterol Sulfate Inhalation Aerosol 108mcg per actuation

MDI, 2 puffs, single dose, fasting

DRUG

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

MDI, 2 puffs, single dose, fasting

Sponsors & Collaborators

  • Intech Biopharm Ltd.

    lead INDUSTRY

Principal Investigators

  • Chao-Hsien Chen, 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
2022-02-24
Primary Completion
2022-04-25
Completion
2022-04-26

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 NCT05300087 on ClinicalTrials.gov