NCT05300087

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Intech Biopharm Ltd. · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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%.

Detailed description

A single-dose, randomized, open-label, two-period, two-sequence, two-treatment, single-centre, two-way crossover bioequivalence study of Albuterol Sulfate inhalation aerosol 108mcg per actuation (equivalent to 90mcg of Albuterol) and Proair HFA (albuterol sulfate) Inhalation Aerosol 90mcg per actuation was carried out under fasting conditions in healthy adults, aged 20-60 years. For each period, 60 subjects were planned to receive a single dose of albuterol inhalation aerosol (2 puffs) according to the pre-determined randomization scheme. Venous blood of each subject was drawn 22 times over the period of 24 hours. Plasma samples were collected and analysed for albuterol concentrations by LC-MS/MS. For each subject, there were 2 dosing periods, separated by a 14-day washout period. During the study, standardized meals were provided to all subjects when institutionalized.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-24
• Primary completion: 2022-04-25
• Completion: 2022-04-26
• First posted: 2022-03-29
• Last updated: 2024-03-18
• Results posted: 2023-09-25

Locations

1 site across 1 country: Taiwan