At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
Salbutamol HFA-152a +1 moredrug
Likely dose
Salbutamol HFA-152a 100 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Salbutamol HFA-152a and Salbutamol HFA-134a for Asthma and Healthy Participants. Completed, enrolled 60 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Healthy Participants
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
First PostedMay 2024
Enrollment StartJun 2024
Primary CompletionOct 2024
Study CompletionOct 2024
TodayJul 2026
First PostedMay 30, 2024
Enrollment StartJun 4, 2024
Primary CompletionOct 18, 2024
Study CompletionOct 22, 2024
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.1 years ago
Interventions
Salbutamol HFA-152adrug
100 µg (ex-valve), given at 20-second intervals.
Salbutamol HFA-134adrug
100 µg (ex-valve), given at 20-second intervals.