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
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2009
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 15, 2012
CompletedFirst Posted
Study publicly available on registry
February 23, 2012
CompletedFebruary 23, 2012
February 1, 2012
1 month
February 15, 2012
February 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics
* 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 Outcomes (2)
Pharmacokinetics
24 hours post dose
Safety and tolerability of BDP HFA nasal aerosol
24 hours post dose
Study Arms (3)
BDP HFA Nasal Aerosol 80 mcg/d
EXPERIMENTALsingle dose, intranasal aerosol
BDP HFA Nasal Aerosol 320 mcg/d
EXPERIMENTALsingle dose, intranasal aerosol
BDP HFA Inhalation Aerosol 320 mcg/d
ACTIVE COMPARATORsingle dose, orally inhaled aerosol
Interventions
Eligibility Criteria
You may qualify if:
- Informed Consent
- Male or female subjects 18-45 years of age
- General good health
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 22621776DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sudeesh Tantry, PhD
Teva Global Respiratory Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
February 23, 2012
Study Start
March 1, 2009
Primary Completion
April 1, 2009
Study Completion
June 1, 2009
Last Updated
February 23, 2012
Record last verified: 2012-02