Nurofen ibuprofen orodispersible tablet disintegration study

• Research type

  Research Study

• Full title

  Randomised, open label, single dose, two-way crossover, single centre study to evaluate the oral disintegration time of a single Nurofen ibuprofen orodispersible tablet (ODT) and two Nurofen ibuprofen ODTs (200mg ibuprofen acid), in fasted healthy volunteers in a clinical setting.

• IRAS ID

  236487

• Contact name

  Annelize Koch

• Contact email

  annelize.koch@simbecorion.com

• Sponsor organisation

  Reckitt Benckiser Healthcare (UK) Ltd

• Duration of Study in the UK

  0 years, 0 months, 22 days

• Research summary

  This study is being funded by Reckitt Benckiser.
  The purpose of this study is to look at how long it takes for orodispersible ibuprofen tablets (ODT) take to disintegrate in the mouth.

  Thirty-three (33) healthy subjects will be recruited in order for evaluable data to be obtained for thirty subjects. Some of the most important entry criteria are:

  -Age: ≥ 18 years ≤ 50 years.
  -Body Mass Index (BMI) of ≥ 18.5 and ≤ 30 kg/m2.
  -Healthy as determined by past medical history, physical examination, vital signs, and laboratory tests at screening.

  The study will be conducted over 1 day (screening and drug administration). There will be 1 visit which includes a screening assessment in the morning and 2x drug administrations each following a 2hr 15min (+/-15min) fast and 4 hours wash out period between administrations.

• REC name

  Wales REC 2

• REC reference

  17/WA/0374

• Date of REC Opinion

  1 Dec 2017

• REC opinion

  Further Information Favourable Opinion