MedTrace Logo

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

NCT05569421 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-08-22

Study results available
· View outcomes & findings →

Summary

The study will evaluate bioequivalence, pharmacokinetics, safety, and tolerability of Budesonide, Glycopyrronium and Formoterol (BGF) metered dose inhaler (MDI) formulated with hydrofluoroolefin (HFO) \[Test\] and hydrofluoroalkane (HFA) \[Reference\] in healthy participants (male or female).

Conditions

Interventions

DRUG

Treatment A: BGF MDI HFO

Participants will receive 4 oral inhalations as a single dose - test formulation; administered during 1 treatment period.

DRUG

Treatment B: BGF MDI HFA

Participants will receive 4 oral inhalations as a single dose - 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
2022-10-11
Primary Completion
2023-04-14
Completion
2023-04-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05569421 on ClinicalTrials.gov