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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 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 108 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05569421
The ClinicalTrials.gov registry entry for NCT05569421 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Treatment A: BGF MDI HFO is the first listed.
NCT05569421 reports 0 study locations.
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.
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