NCT01537692

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-04-01
• Completion: 2009-06-01
• First posted: 2012-02-23
• Last updated: 2012-02-23