A Study to Assess the Lung Exposure Bioequivalence 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

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 17, 2024

Primary Completion Date

February 27, 2025

Study Completion Date

February 27, 2025

Conditions
Healthy
Interventions
DRUG

Treatment A: BGF MDI HFA

Participants will receive 4 oral inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal.

DRUG

Treatment B: BGF MDI HFO

Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal.

DRUG

Treatment C: BGF MDI HFO

Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose without spacer with charcoal.

DEVICE

AeroChamber Plus Flow-Vu Spacer

Participants will receive 4 inhalations of BGF MDI HFA (treatment A) and BGF MDI HFO (Treatment B) as a single dose with AeroChamber Plus Flow-Vu spacer.

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

AstraZeneca

INDUSTRY