Hydromorphone/naloxone 2 phase PK study

• Research type

  Research Study

• Full title

  An open-label, randomised, crossover, single-dose, pilot and definitive phase study in healthy subjects to compare the pharmacokinetics of two formulations of a hydromorphone/naloxone prolonged release capsule 4/8 mg with a hydromorphone prolonged release capsule 4 mg (Palladone®-SR) and a hydropmorphone prolonged release capsule 4 mg (Palladone®-SR) plus naloxone prolonged release tablet 8 mg, in either a fasted or fed state.

• IRAS ID

  148549

• Contact name

  Ronnie Beboso

• Contact email

  bebosor@biokineticeurope.com

• Sponsor organisation

  Mundipharma Research Limited

• Eudract number

  2013-005523-16

• REC name

  HSC REC A

• REC reference

  14/NI/0016

• Date of REC Opinion

  4 Mar 2014

• REC opinion

  Favourable Opinion