A study to compare 2 types of Ibuprofen in Healthy Volunteers

• Research type

  Research Study

• Full title

  A randomised, single dose, 4-way crossover, open label, pharmacokinetic study comparing a 2% (w/v) suspension of ibuprofen ml(400 mg/20 ml, Nurofen for Children®) with a Swiss reference 2% (w/v) suspension of ibuprofen (400 mg/20 ml Algifor® Dolo Junior) in the fed and fasted states.

• IRAS ID

  171575

• Contact name

  Robert Adams

• Contact email

  robert.adams@simbec.com

• Sponsor organisation

  RB

• Eudract number

  2013-003366-14

• Duration of Study in the UK

  0 years, 2 months, 12 days

• Research summary

  This study is being funded by Reckitt Benckiser. The purpose of this study is to compare 2 different types of ibuprofen product when they are given with and without food. To help compare the 2 products, blood samples will be taken at specific times during the study, after subjects have taken either type of ibuprofen. Measuring drug levels in blood will help to find out how much ibuprofen has been absorbed.

  Twenty eight (28) participants are needed for this study, some of the most important entry criteria are:

  • You are aged between 18 and 50 and are considered healthy
  • You are not taking any medication
  • You are a non-smoker

  The study will consist of a screening visit, 4 dosing visits (there will be at least 3 days between dosing visits), and one follow-up visit. The post-study follow-up will take place 2 to 7 days after the last dosing period.

• REC name

  Wales REC 1

• REC reference

  15/WA/0114

• Date of REC Opinion

  13 May 2015

• REC opinion

  Further Information Favourable Opinion