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COMPLETED
NCT06139991
PHASE1

Study to Assess the Pharmacokinetic Bioequivalence of Budesonide and Albuterol With an Alternate Propellant Compared to Current Propellant.

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This study will investigate the Pharmacokinetic (PK) and safety of Budesonide and albuterol (BDA) metered dose inhaler (MDI) HFO and BDA MDI HFA in healthy male and female participants.

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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2023-11-16

Completion Date

2024-05-04

Last Updated

2026-05-07

Healthy Volunteers

Yes

Interventions

DRUG

Treatment A (BDA MDI HFO)

Randomized participants will receive Treatment A (BDA MDI HFO) on Day 1 under fasted condition.

DRUG

Treatment B (BDA MDI HFA)

Randomized participants will receive Treatment B (BDA MDI HFA) on Day 1 under fasted condition.

Locations (1)

Research Site

Glendale, California, United States