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A Study to Investigate the Pharmacokinetics and Safety of Beclomethasone Dipropionate Administered by Breath-Actuated Inhaler and Metered-Dose Inhaler in Healthy Adults

NCT02030457 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-11-09

No results posted yet for this study

Summary

This study is designed to compare the systemic exposure of orally inhaled beclomethasone dipropionate inhalation aerosol delivered via BAI to that delivered via MDI.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Beclomethasone dipropionate BAI

Breath Activated Inhaler (BAI)

DRUG

Beclomethasone dipropionate MDI

Metered Dose Inhaler (MDI)

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-04-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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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 NCT02030457 on ClinicalTrials.gov