Hydromorphone/Naloxone Pilot and Definitive 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 three formulations of a hydromorphone/naloxone prolonged release capsule with a hydromorphone prolonged release capsule 4 mg (Palladone® SR) plus naloxone prolonged release tablet 8 mg, in a fasted and fed state.
IRAS ID
177284
Contact name
Heather Withers
Contact email
Sponsor organisation
Mundipharma Research Ltd
Eudract number
2015-000437-67
Duration of Study in the UK
0 years, 5 months, 23 days
Research summary
This is a 2 part healthy volunteer study. Part 1 is a pilot phase, part 2 is a definitive phase. The purpose of this study is to compare and confirm bioequivalence of 3 formulations of a combined opioid analgesic to an already marketed product and a prolonged release tablet, for pain management.\n\nThe pilot phase will incorporate 2 groups (fed and fasted) & four study periods, and will determine which formulation will be tested in the definitive phase. \n \nThe definitive phase will incorporate 2 groups (fed and fasted) & two study periods and will examine the equivalence of the selected new combination formulation to the marketed product.\n\nIf a suitable formulation cannot be identified from the pilot phase, the definitive phase may not proceed.\n\nThe study will recruit healthy male and female volunteers aged between 18 and 55 inclusive. The total number of volunteers will be 156; 32 for the pilot phase and 124 for the definitive phase.\n\nThe duration of the study for each volunteer in the pilot phase will be approximately 52 days, including the 21 day screening period.\n\nThe duration of the study for each volunteer in the definitive phase will be approximately 38 days, including the 21 day screening period.\n
REC name
HSC REC B
REC reference
15/NI/0035
Date of REC Opinion
8 Apr 2015
REC opinion
Further Information Favourable Opinion