A Study to Determine the Effect of Food on OXN PR Tablet 80mg/40mg.

• Research type

  Research Study

• Full title

  An open-label, single-dose, 3-treatment, 3-period, randomised crossover study in healthy subjects to assess the pharmacokinetics of oxycodone and naloxone after administration of OXN PR tablet 80mg/40mg in a fed and fasted state, and oxycodone hydrochloride immediate release liquid 20mg (20mL of 5mg/5mL solution) and naloxone hydrochloride liquid 10mg (10mL of 1mg/1mL solution) in a fasted state.

• IRAS ID

  72242

• Contact name

  David J A Bell

• Sponsor organisation

  Mundipharma Research Limited

• Eudract number

  2010-023010-31

• Research summary

  This study is designed to determine the effect of food on the bioavailability of the combination study drug and to compare the PK and safety of the the study drug in tablet versus liquid format.

• REC name

  HSC REC B

• REC reference

  11/NI/0002

• Date of REC Opinion

  25 Feb 2011

• REC opinion

  Further Information Favourable Opinion