Abstract
Aerosol of Fluticasone Propionate (FP), a new topical adrenocorticosteroid developed for treatment of nasal allergy, was examined for its tolerance and pharmacokinetic profile, in healthy male volunteers, with single dosing (100μg, 200μg, 400μg or placebo; n=6) and multiple dosing (either 400μg or placebo ; n=5; 14 days), and the following results were obtained.
1. The following tests were performed: subjective symptoms, anterior rhinoscopy, physical examinations, adrenal function tests, clinical laboratory tests, biochemical urinalysis, nasal and pharyngeal fungal tests, and nasal mucociliary transport test. No abnormality attributable to this drug was observed except for one case receiving single dose of 100μg, who felt transient intranasal irritancy immediately after dosing. Based on these results, it was confirmed that this drug was well tolerated as far as it was administered for not longer than 14 consecutive days in the dose of 400μg daily.
2, Concentrations of FP (as the unmetabolised drug) present in plasma following the single doses of 200μg and 400μg, and multiple dosing of 400μg/day, were all below the detectable limit (50pg/ml).
