drugset / Trial / NCT06297668

A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-Generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer

NCT06297668

Phase 1 Completed 42 enrolled AstraZeneca Parexel · collab
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2024-04-29
Primary completion
2024-06-11
Completion
2024-06-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 160 ug Inhaled
Comparator Formoterol Other / unclassified 4.8 ug Inhaled
Comparator Glycopyrronium Unknown 7.2 ug Inhaled