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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Teva Pharmaceutical Industries

ClinicalTrials.gov Identifier:

NCT01537692

First received: February 15, 2012

Last updated: February 22, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 15, 2012

Last Updated Date

February 22, 2012

Start Date ^ICMJE

March 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetics [ Time Frame: 24 hours post dose ] [ Designated as safety issue: No ]

Area under the plasma concentration time curve until the last measurable value (AUClast) for 17-BMP
Maximum plasma concentration (Cmax) for 17-BMP

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01537692 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics [ Time Frame: 24 hours post dose ] [ Designated as safety issue: No ]
- 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
Safety and tolerability of BDP HFA nasal aerosol [ Time Frame: 24 hours post dose ] [ Designated as safety issue: No ]
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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Allergic Rhinitis

Intervention ^ICMJE

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

Study Arm (s)

Experimental: BDP HFA Nasal Aerosol 80 mcg/d
single dose, intranasal aerosol

Intervention: Drug: BDP HFA Nasal Aerosol
Experimental: BDP HFA Nasal Aerosol 320 mcg/d
single dose, intranasal aerosol

Intervention: Drug: BDP HFA Nasal Aerosol
Active Comparator: BDP HFA Inhalation Aerosol 320 mcg/d
single dose, orally inhaled aerosol

Intervention: Drug: BDP HFA Inhalation Aerosol (QVAR)

Publications *

Ratner PH, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Pharmacokinetic profile of beclomethasone dipropionate hydrofluoroalkane after intranasal administration versus oral inhalation in healthy subjects: results of a single-dose, randomized, open-label, 3-period crossover study. Clin Ther. 2012 Jun;34(6):1422-31. Epub 2012 May 22.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01537692

Other Study ID Numbers ^ICMJE

BDP-AR-101

Has Data Monitoring Committee

Responsible Party

Teva Pharmaceutical Industries

Study Sponsor ^ICMJE

Teva Pharmaceutical Industries

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Sudeesh Tantry, PhD

Teva Global Respiratory Research

Information Provided By

Teva Pharmaceutical Industries

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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