Last reviewed · How we verify
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.
Details
| Lead sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2009-03 |
| Completion | 2009-06 |
Conditions
- Allergic Rhinitis
Interventions
- BDP HFA Nasal Aerosol
- BDP HFA Nasal Aerosol
- BDP HFA Inhalation Aerosol (QVAR)
Primary outcomes
- Pharmacokinetics — 24 hours post dose
* Area under the plasma concentration time curve until the last measurable value (AUClast) for 17-BMP * Maximum plasma concentration (Cmax) for 17-BMP