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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537692
• Other study ID #: BDP-AR-101
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2012
• Last updated: February 22, 2012
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: February 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Drug:
• BDP HFA Nasal Aerosol
BDP HFA Nasal 80mcg
• BDP HFA Nasal Aerosol
BDP HFA Nasal 320mcg
• BDP HFA Inhalation Aerosol (QVAR)
BDP HFA Oral 320mcg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetics	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	No
Secondary	Safety and tolerability of BDP HFA nasal aerosol	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	No