NCT06139991

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Eligible participant will receive 3 single-dose treatments; 2 doses of BDA MDI HFA and 1 dose of BDA MDI HFO. * Treatment A: 2 inhalations, single dose of BDA MDI HFO 80/90 μg (test formulation) * Treatment B: 2 inhalations, single dose of BDA MDI HFA 80/90 μg (reference formulation) Participants will be randomly assigned to receive any 1 of the 3 treatment sequences of ABB, BBA or BAB. The study will comprise of: * A screening period of maximum 28 days. * Three Treatment periods will be up to approximately 22 days (including Follow-up). * A final follow-up calls within 3-7 days after the last dose of study intervention. Each participant has to be involved in the study for up to 48 days.

Conditions

• Heathy Participants

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-16
• Primary completion: 2024-05-04
• Completion: 2024-05-04
• First posted: 2023-11-18
• Last updated: 2024-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study