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Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol

NCT01537692 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-02-23

No results posted yet for this study

Summary

The purpose of this study is to compare the systemic levels of beclomethasone 17 monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in healthy volunteers.

Conditions

  • Allergic Rhinitis

Interventions

DRUG

BDP HFA Nasal Aerosol

BDP HFA Nasal 80mcg

DRUG

BDP HFA Nasal Aerosol

BDP HFA Nasal 320mcg

DRUG

BDP HFA Inhalation Aerosol (QVAR)

BDP HFA Oral 320mcg

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Sudeesh Tantry, PhD · Teva Global Respiratory Research

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-04-30
Completion
2009-06-30

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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 NCT01537692 on ClinicalTrials.gov