NCT06433908

A Study to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152A (Test) or HFA-134A (Reference) in Healthy Participants Aged 18 to 55 Inclusive

A Phase 1, Randomized, Open-label, Single Dose, 2-treatment Arm (200 μg and 800 μg), 4-way Crossover Study in Healthy Participants Aged 18 to 55 to Compare the Pharmacokinetics of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152A (Test) and HFA-134A (Reference)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to characterize the PK of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a (test), and to compare with an MDI containing propellant HFA-134a (reference).

Conditions

• Asthma
• Healthy Participants

Interventions

Type	Name	Description
DRUG	Salbutamol HFA-152a	100 µg (ex-valve), given at 20-second intervals.
DRUG	Salbutamol HFA-134a	100 µg (ex-valve), given at 20-second intervals.

Timeline

• Start date: 2024-06-04
• Primary completion: 2024-10-18
• Completion: 2024-10-22
• First posted: 2024-05-30
• Last updated: 2026-01-12
• Results posted: 2026-01-12

Locations

1 site across 1 country: Netherlands