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

NCT06139991 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • Heathy Participants

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2024-05-04
Completion
2024-05-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06139991 on ClinicalTrials.gov