Study to assess the pharmacokinetic bioequivalence of budesonide and albuterol with an alternate propellant compared to current propellant.

Study identifier:D6933C00001

ClinicalTrials.gov identifier:NCT06139991

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, randomized, double-blind, single-dose, partial replicate, 3-period cross-over study to assess the total systemic exposure bioequivalence of budesonide and albuterol delivered by BDA MDI Hydrofluoroolefin (HFO) compared with BDA MDI (Hydrofluoroalkene) HFA.

Medical condition

Heathy participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Treatment A (BDA MDI HFO), Treatment B (BDA MDI HFA)

Sex

All

Actual Enrollment

66

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 16 Nov 2023
Primary Completion Date: 04 May 2024
Study Completion Date: 04 May 2024

Study design

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

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria