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NCT05569421 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Total Systemic Exposure Bioequivalence of of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
NCT05569421: Completed Phase 1 study, sponsored by AstraZeneca.
NCT05569421 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 108 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05569421, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
Study Summary
The study will evaluate bioequivalence, pharmacokinetics, safety, and tolerability of Budesonide, Glycopyrronium and Formoterol (BGF) metered dose inhaler (MDI) formulated with hydrofluoroolefin (HFO) \[Test\] and hydrofluoroalkane (HFA) \[Reference\] in healthy participants (male or female).
Primary Outcome
The AUCinf of budesonide, glycopryrronium and formoterol in participants was evaluated.
Interventions
- DRUG Treatment A: BGF MDI HFO
- DRUG Treatment B: BGF MDI HFA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2022-10-11 |
| Est. Completion | 2023-04-14 |
| Phase | Phase 1 |
What the finished NCT05569421 record still lists
NCT05569421 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 2 interventions - of which Treatment A: BGF MDI HFO is the first listed.
NCT05569421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05569421 about?
NCT05569421 is a clinical study titled "A Study to Assess the Total Systemic Exposure Bioequivalence of of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant". The study will evaluate bioequivalence, pharmacokinetics, safety, and tolerability of Budesonide, Glycopyrronium and Formoterol (BGF) metered dose inhaler (MDI) formulated with hydrofluoroolefin (HFO) \[Test\] and hydrofluoroalkane (HFA) \[Reference\] in healthy participants (male or female).
What is the current status of trial NCT05569421?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2022-10-11. Estimated completion is 2023-04-14.
What interventions are being tested in trial NCT05569421?
The interventions under investigation include: Treatment A: BGF MDI HFO (DRUG), Treatment B: BGF MDI HFA (DRUG).
Who is sponsoring clinical trial NCT05569421?
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 NCT05569421's enrollment target sits among peer trials
108 523rd of 2000 higher than 1,470 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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