A PK, dose-proportionality assessment of OXN PR tablet new strengths

• Research type

  Research Study

• Full title

  An open-label, single-dose, 7-treatment, 5-period, randomised incomplete crossover study to compare the dose proportionality of an oxycodone/naloxone prolonged release tablet at different strengths (2.5 mg/1.25 mg, 10 mg/5 mg, 15 mg/7.5 mg, 30 mg/15 mg, 40 mg/20 mg, 60 mg/30 mg and 80 mg/40 mg), administered to healthy subjects in a fasted state.

• IRAS ID

  73079

• Contact name

  David J A Bell

• Sponsor organisation

  Mundipharma Research Limited

• Eudract number

  2010-023684-18

• Research summary

  This is a study of an opioid analgesic/opioid antagonist combination to assess the pharmacokinetics and dose-proportionality of prolonged release multiple strength tablets.

• REC name

  HSC REC B

• REC reference

  11/NI/0022

• Date of REC Opinion

  30 Mar 2011

• REC opinion

  Further Information Favourable Opinion