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

February 22, 2012 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Randomized, Open-Label, 3-Period Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of BDP HFA Nasal Aerosol in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed Consent
  • Male or female subjects 18-45 years of age
  • General good health

Exclusion Criteria:

  • History of physical findings of nasal pathology (within 60 days prior to Screening Visit)
  • Participation in any investigational drug study 30 days preceding Screening Visit
  • History of respiratory infection/disorder with 28 days preceding Screening Visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BDP HFA Nasal Aerosol 80 mcg/d
single dose, intranasal aerosol
Drug: BDP HFA Nasal Aerosol
BDP HFA Nasal 80mcg
Drug: BDP HFA Nasal Aerosol
BDP HFA Nasal 320mcg
Experimental: BDP HFA Nasal Aerosol 320 mcg/d
single dose, intranasal aerosol
Drug: BDP HFA Nasal Aerosol
BDP HFA Nasal 80mcg
Drug: BDP HFA Nasal Aerosol
BDP HFA Nasal 320mcg
Active Comparator: BDP HFA Inhalation Aerosol 320 mcg/d
single dose, orally inhaled aerosol
Drug: BDP HFA Inhalation Aerosol (QVAR)
BDP HFA Oral 320mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: 24 hours post dose
  • Area under the plasma concentration time curve until the last measurable value (AUClast) for 17-BMP
  • Maximum plasma concentration (Cmax) for 17-BMP
24 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: 24 hours post dose
  • Area under the plasma concentration time curve extrapolated to infinity (AUC0-inf), time to mean peak plasma concentration (Tmax), and the terminal elimination half-life (t1/2) for 17-BMP
  • AUClast, AUC0-inf, Cmax, Tmax, t1/2 for BDP
24 hours post dose
Safety and tolerability of BDP HFA nasal aerosol
Time Frame: 24 hours post dose
Change from baseline in safety and tolerability endpoints - including Adverse events, changes in vital signs (blood pressure and pulse rate) and ENT exams (every visit) and safety laboratory assessments and physical exams (end of study)
24 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Study Director: Sudeesh Tantry, PhD, Teva Global Respiratory Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Estimate)

February 23, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDP-AR-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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