Orodispersible ibuprofen fasted comparative bioavailability study

• Research type

  Research Study

• Full title

  An open label, randomised, single dose, three-way crossover study to compare the bioavailability of 400mg ibuprofen from 2 x 200mg ibuprofen acid orodispersable tablets, 2 x 200mg ibuprofen acid tablets and 2 x 342mg ibuprofen lysine tablets in fasted healthy volunteers

• IRAS ID

  220743

• Contact name

  Annelize Koch

• Contact email

  annelize.koch@simbecorion.com

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Ltd

• Eudract number

  2016-002998-35

• Duration of Study in the UK

  0 years, 8 months, 18 days

• Research summary

  This study is being funded by Reckitt Benckiser. The purpose of this study is to compare 3 different types (formulations) of Ibuprofen when they are given without food. To help compare the 3 products, blood samples will be taken at specific times during the study after subjects have taken one of ibuprofen formulations. Measuring drug levels in blood will help to find out how much ibuprofen has been absorbed into the blood stream from the stomach/gastro-intestinal tract.

  Thirty-Six (36) subjects are to be enrolled with the requirement that 32 will complete the study. Some of the most important entry criteria are:

  - Subjects are aged between 18 and 50 and are considered healthy
  - Subjects are not taking any medication
  - Subjects are a non-smoker or ex-smoker who hasn't smoked in the last 6 months

  The study will consist of a screening visit, 3 treatment visits (there will be at least 3 to 7 days between treatment visits), and one post study follow-up visit. Each treatment visit will include 1 overnight stay. The post study follow-up will take place 2 to 7 days after the final blood draw of treatment period 3.

• REC name

  Wales REC 1

• REC reference

  17/WA/0003

• Date of REC Opinion

  20 Feb 2017

• REC opinion

  Further Information Favourable Opinion