Naproxen sodium (2 x 220 mg) fasted comparative bioavailability study.

• Research type

  Research Study

• Full title

  A randomised, single-dose, 2-way crossover, open-label, comparative bioavailability study comparing Test naproxen sodium tablets (2 x 220 mg) with commercially available Reference naproxen sodium tablets (2 x 220 mg) in the fasted state

• IRAS ID

  210684

• Contact name

  Girish Sharma

• Contact email

  girish.sharma@simbec.com

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Ltd

• Eudract number

  2016-000651-27

• Duration of Study in the UK

  0 years, 1 months, 21 days

• Research summary

  This study is being funded by Reckitt Benckiser. The purpose of this study is to compare 2 different type of naproxen when they are given 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 naproxen. Measuring drug levels in blood will help to find out how much naproxen has been absorbed.

  Eighteen (18) subjects are to be enrolled with the requirement that 16 will complete the study. Further subjects can be recruited if more than 2 subjects do not 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 of ex-smoker who hasn't smoked in the last 6 months

  The study will consist of a screening visit, 2 dosing visits (there will be at least 5 to 8 days between dosing visits), and one follow-up visit. Each dosing visit/ treatment visit will include 2 overnight stays and 3 repeat visits for blood draws. The post study follow-up will take place 2 to 7 days after the final blood draw of treatment period 2.

• REC name

  Wales REC 1

• REC reference

  16/WA/0247

• Date of REC Opinion

  27 Sep 2016

• REC opinion

  Further Information Favourable Opinion