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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

February 15, 2012
February 22, 2012
March 2009
April 2009   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01537692 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Allergic Rhinitis
  • 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
  • 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)
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. doi: 10.1016/j.clinthera.2012.04.023. Epub 2012 May 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01537692
BDP-AR-101
No
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Study Director: Sudeesh Tantry, PhD Teva Global Respiratory Research
Teva Pharmaceutical Industries
February 2012

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