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

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).

Timeline

Start

2024-06-04

Primary completion

2024-10-18

Completion

2024-10-22

Outcome

Mixed primary results

registry Ratio of Geometric Least Squares Mean 0.9649 (90% CI 0.8695 to 1.0707) NCT06433908 ↗

registry Ratio of Geometric Least Squares Mean 1.2941 (90% CI 1.1795 to 1.4199) NCT06433908 ↗

registry Ratio of Geometric Least Squares Mean 0.9475 (90% CI 0.7746 to 1.1590) NCT06433908 ↗

registry Ratio of Geometric Least Squares Mean 1.2032 (90% CI 1.1620 to 1.2459) NCT06433908 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Salbutamol	Unknown	200 ug	Inhaled
Subject	Salbutamol	Unknown	800 ug	Inhaled

Indications