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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
30
BDP HFA Nasal 80mcg
BDP HFA Nasal 320mcg
BDP HFA Oral 320mcg
Pharmacokinetics
* Area under the plasma concentration time curve until the last measurable value (AUClast) for 17-BMP * Maximum plasma concentration (Cmax) for 17-BMP
Time frame: 24 hours post dose
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
Time frame: 24 hours post dose
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)
Time frame: 24 hours post dose
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