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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

NCT05477108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-08-28

Study results available
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Summary

The study will assess the Pharmacokinetic (PK) and safety of BGF MDI \[Budesonide/glycopyrronium/formoterol (BGF) metered dose inhaler (MDI)\] formulated with 2 different propellants :Hydrofluoroolefin (HFO) and Hydrofluoroalkane (HFA) with oral activated charcoal in healthy subjects (male or female).

Conditions

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.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-29
Primary Completion
2023-04-11
Completion
2023-04-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477108 on ClinicalTrials.gov