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NCT06139991 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Pharmacokinetic Bioequivalence of Budesonide and Albuterol With an Alternate Propellant Compared to Current Propellant.
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT06139991: Completed Phase 1 study, sponsored by AstraZeneca.
NCT06139991 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06139991, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
This study will investigate the Pharmacokinetic (PK) and safety of Budesonide and albuterol (BDA) metered dose inhaler (MDI) HFO and BDA MDI HFA in healthy male and female participants.
Primary Outcome
The AUClast of budesonide and albuterol will be evaluated to assess the bioequivalence of the total systemic exposure of budesonide and albuterol administered.
Interventions
- DRUG Treatment A (BDA MDI HFO)
- DRUG Treatment B (BDA MDI HFA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2023-11-16 |
| Est. Completion | 2024-05-04 |
| Phase | Phase 1 |
What the finished NCT06139991 record still lists
NCT06139991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 2 interventions - of which Treatment A (BDA MDI HFO) is the first listed.
NCT06139991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06139991 about?
NCT06139991 is a clinical study titled "Study to Assess the Pharmacokinetic Bioequivalence of Budesonide and Albuterol With an Alternate Propellant Compared to Current Propellant.". This study will investigate the Pharmacokinetic (PK) and safety of Budesonide and albuterol (BDA) metered dose inhaler (MDI) HFO and BDA MDI HFA in healthy male and female participants.
What is the current status of trial NCT06139991?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2023-11-16. Estimated completion is 2024-05-04.
What interventions are being tested in trial NCT06139991?
The interventions under investigation include: Treatment A (BDA MDI HFO) (DRUG), Treatment B (BDA MDI HFA) (DRUG).
Who is sponsoring clinical trial NCT06139991?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06139991's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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