Clinical Studies of Fluticasone Propionate Aerosol (1st Report)

DOI

Bibliographic Information

Other Title
  • Fluticasone propionateエアゾール剤の臨床的検討 (第1報)
  • PhaseI Studies in Single and Multiple Dosing
  • 単回および連続投与による臨床第I相試験

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.<BR>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.<BR>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).

Journal

  • OTOLOGIA FUKUOKA

    OTOLOGIA FUKUOKA 38 (3Supplement1), 299-309, 1992

    JIBI TO RINSHO KAI

Keywords

Details 詳細情報について

  • CRID
    1390001205500385024
  • NII Article ID
    130004403821
  • DOI
    10.11334/jibi1954.38.3supplement1_299
  • ISSN
    04477227
  • Text Lang
    ja
  • Data Source
    • JaLC
    • CiNii Articles
  • Abstract License Flag
    Disallowed

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