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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

NCT06433908 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-12

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2024-10-18
Completion
2024-10-22

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

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 NCT06433908 on ClinicalTrials.gov