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 B, 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