Ibuprofen 4% (w/v) Pivotal Bioequivalence Study
Research type
Research Study
Full title
A randomised, single-dose, 4-way crossover, open-label, pharmacokinetic study comparing a 4% (w/v) suspension of ibuprofen with a reference 2% (w/v) suspension of ibuprofen in the fed and fasted states.
IRAS ID
195282
Contact name
Girish Sharma
Contact email
Sponsor organisation
RB
Eudract number
2015-003894-13
Duration of Study in the UK
0 years, 2 months, 14 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 four (24) participants are needed for this 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-smokerThe 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 2
REC reference
16/WA/0015
Date of REC Opinion
22 Jan 2016
REC opinion
Favourable Opinion