A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C). - Trial NCT06297668
Access comprehensive clinical trial information for NCT06297668 through Pure Global AI's free database. This Phase 1 trial is sponsored by AstraZeneca and is currently Not yet recruiting. The study focuses on Chronic Obstructive Pulmonary Disease. Target enrollment is 42 participants.
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Study Focus
Sponsor & Location
AstraZeneca
Timeline & Enrollment
Phase 1
Apr 26, 2024
Jun 13, 2024
Primary Outcome
Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI,Maximum Observed Concentration (Cmax) of BGF MDI
Summary
This study aims to assess the effect on total systemic exposure and to characterize exposure
 BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total
 systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF
 MDI HFA with a spacer.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06297668
Non-Device Trial