A study to assess drug absorption of fixed dose combinations of budesonide, glycopyrronium, and formoterol

Study identifier:D5985C00001

ClinicalTrials.gov identifier:NCT04600505

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Single blind, 3-Period, 3-Treatment, Single-dose, Crossover Study to Assess the Relative Bioavailability of BGF Propellant 1 and BGF Propellant 2 Compared with BGF MDI HFA in Healthy Subjects

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Treatment A, Treatment A, Treatment A, Treatment A, Treatment A, Treatment A, Treatment B, Treatment B, Treatment B, Treatment B, Treatment B, Treatment B, Treatment C, Treatment C, Treatment C, Treatment C, Treatment C, Treatment C

Sex

Male

Actual enrollment

47

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 19 Oct 2020
Primary Completion Date: 17 May 2021
Study Completion Date: 17 May 2021

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2022 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Parexel International

Inclusion and exclusion criteria