Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant

PHASE1CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

July 29, 2022

Primary Completion Date

April 11, 2023

Study Completion Date

April 11, 2023

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Treatment A (BGF MDI HFO with oral activated charcoal)

Subject will receive 4 inhalations as a single dose with oral activated charcoal - test formulation; administered during 1 Treatment Period.

DRUG

Treatment B (BGF MDI HFA with oral activated charcoal)

Subject will received 4 inhalations as a single dose with oral activated charcoal - reference formulation; administered during 2 Treatment Periods.

Trial Locations (1)

21225

Research Site, Brooklyn

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

AstraZeneca

INDUSTRY