Flurbiprofen 3-way pivotal PK study, Version Final

• Research type

  Research Study

• Full title

  An open label, randomised, single dose, 3-way crossover study to compare the bioavailability of an 8.75mg flurbiprofen lozenge with that of two 8.75mg flurbiprofen sprays (with different flavours and excipients) in adult healthy volunteers

• IRAS ID

  87178

• Sponsor organisation

  Reckitt Benckiser Healthcare UK Ltd

• Eudract number

  2011-003332-31

• Research summary

  The sponsor of this study has developed a new spray formulation of an Investigational Medicinal Product (IMP) which will be used to treat sore throats and this study is designed to look at different variations of this formulation (in terms of flavour and binding ingredients) compared to the currently available lozenge formulation. The aim is to identify a spray formulation that is absorbed into the bloodstream at the same rate and extent as the existing lozenge.This study will be performed at one site within the UK. Volunteers will receive a single dose of each of the three formulations in a random order on separate occasions during the study. The total duration of the study will be 35 days.

• REC name

  Scotland A REC

• REC reference

  11/IE/0140

• Date of REC Opinion

  19 Sep 2011

• REC opinion

  Further Information Favourable Opinion