Comparing 2 tablets containing oxycodone and naloxone; version 1

• Research type

  Research Study

• Full title

  Relative bioavailability trial to investigate the pharmacokinetics of a new prolonged-release oxycodone/naloxone combination product compared to the marketed Targin® tablet under fasted and fed conditions in healthy subjects (12-020)

• IRAS ID

  113523

• Contact name

  Gary Peters

• Eudract number

  2012-002311-25

• Research summary

  Targin (also called Targinact) is a widely used medicine for treating severe pain. It contains oxycodone: a strong painkiller, which blocks pain signals from nerves in the brain and spinal cord. It also contains naloxone to reduce constipation, which is a side effect of oxycodone. GRT7010 is a new experimental medicine for severe pain. Like Targin, it contains oxycodone and naloxone. We hope that GRT7010 will work as well as Targin. In this study, We'll test single doses of Targin and GRT7010, to compare their blood levels and side effects. We'll give Targin and GRT7010 to 16 healthy men, aged 18??55 years. Participants will have 4 study sessions, and take a single dose of study medicine in each session. They??ll take each study medicine twice: once on an empty stomach, and once after a fatty breakfast. Participants will take about 7 weeks to finish the study. They??ll stay on the ward for 3 nights in a row in each of their 4 study sessions, and make 2 outpatient visits. A pharmaceutical company (GrǬnenthal) is funding the study. The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0432

• Date of REC Opinion

  23 Oct 2012

• REC opinion

  Further Information Favourable Opinion