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An Open-Label, 2-Part, Randomized, Crossover Study to Compare the Bioavailability of Intranasal Administration of 200 and 400 µg of OPTINOSE FLUTICASONE With 400 µg of Flonase (Fluticasone Propionate) Nasal Spray (Part 1), and Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE FLUTICASONE With 440 µg of Flovent HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2) (Current Investigation is Part 2 Only)

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Trial Profile

An Open-Label, 2-Part, Randomized, Crossover Study to Compare the Bioavailability of Intranasal Administration of 200 and 400 µg of OPTINOSE FLUTICASONE With 400 µg of Flonase (Fluticasone Propionate) Nasal Spray (Part 1), and Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE FLUTICASONE With 440 µg of Flovent HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2) (Current Investigation is Part 2 Only)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

Most Recent Events

  • 12 Nov 2019 Results of Part I & II studies assessing pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance published in the Clinical Therapeutics
  • 18 Sep 2017 According to an OptiNose media release, the U.S. Food & Drug Administration (FDA) approved the Company's New Drug Application (NDA) for XHANCE for the treatment of nasal polyps in patients 18 years of age and older.
  • 09 May 2017 According to a OptiNose media release, The FDA has set a target date to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) of September 2017.

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