Steady-state PK of oxycodone and naloxone from OXN PR tablets (112769)

• Research type

  Research Study

• Full title

  An open-label, multiple-dose, 2-treatment, 2-period, randomised crossover study in healthy subjects to determine the steady-state pharmacokinetics of oxycodone and naloxone from OXN PR tablet 80 mg/40 mg and OXN PR tablet 40 mg/20 mg in healthy subjects.

• IRAS ID

  99604

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Mundipharma Research Ltd

• Eudract number

  2011-004262-15

• Research summary

  The Sponsor is developing a new strength of Oxycodone/Naloxone Prolonged Release (OXN PR) tablet. OXN PR tablets contain a combination of oxycodone/naloxone at fixed concentrations for the treatment of chronic pain. The naloxone component acts to prevent opioid-induced constipation which is often caused by oxycodone. The study will compare how the body deals with two strengths of the study drug Oxycodone/naloxone prolonged release tablets (80 mg/40 mg vs 40/20 mg) at the point when the amount of study drug in the body is at a consistent or steady level (steady state).

• REC name

  HSC REC A

• REC reference

  12/NI/0061

• Date of REC Opinion

  9 May 2012

• REC opinion

  Further Information Favourable Opinion