Comparison of Five Formulations of an IMP (a lozenge and 4 sprays)

• Research type

  Research Study

• Full title

  An open label, randomised, single dose, 5-way cross over pilot study to compare the rate and extent of absorption of a 8.75mg Flurbiprofen lozenge with flavour and excipient base variants of a 8.75mg Flurbiprofen spray.

• IRAS ID

  68603

• Contact name

  Stephen Smith

• Sponsor organisation

  Reckitt Benckiser Healthcare UK Ltd

• Eudract number

  2010-022899-32

• Research summary

  The sponsor of this study has developed a new spray formulation of an Investigational Medicinal Product (IMP) 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 spray formulation will then be further developed.Volunteers will receive a single dose of each of the five formulations in a random order onoseparate occasions during the study.The maximum duration of the study from screening until the Follow-up Visit could be up to 51 days for each volunteer (this allows for a maximum of 7 days between each of the 5 doses and for the Follow-up Visit occurring a maximum of 8 days after the last dose).

• REC name

  Scotland A REC

• REC reference

  10/IEC02/31

• Date of REC Opinion

  19 Jan 2011

• REC opinion

  Further Information Favourable Opinion