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
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Drug: BDP HFA Nasal Aerosol
Drug: BDP HFA Inhalation Aerosol (QVAR)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Randomized, Open-Label, 3-Period Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of BDP HFA Nasal Aerosol in Healthy Volunteers

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 30
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BDP HFA Nasal Aerosol 80 mcg/d
single dose, intranasal aerosol
Drug: BDP HFA Nasal Aerosol
BDP HFA Nasal 80mcg
Experimental: BDP HFA Nasal Aerosol 320 mcg/d
single dose, intranasal aerosol
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537692

Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Sudeesh Tantry, PhD Teva Global Respiratory Research
  More Information

No publications provided by Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01537692     History of Changes
Other Study ID Numbers: BDP-AR-101
Study First Received: February 15, 2012
Last Updated: February 22, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014