Bioequivalence Study of two nasal Fluticasone Dosage Forms.

• Research type

  Research Study

• Full title

  An Open-Label, 2-Part, Randomized, Crossover Study to Compare the Bioavailability of Intranasal Administration of 200 and 400 µg of OPTINOSE TM 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 TM FLUTICASONE with 440 µg of Flovent® HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2).

• IRAS ID

  157088

• Contact name

  Stephen Smith

• Contact email

  stephen.smith@celerion.com

• Sponsor organisation

  OptiNose UK

• Eudract number

  2014-001872-73

• REC name

  HSC REC A

• REC reference

  14/NI/0083

• Date of REC Opinion

  17 Jun 2014

• REC opinion

  Further Information Favourable Opinion