Hydromorphone/naloxone pilot and definitive PK study
Research type
Research Study
Full title
An open-label, single-dose, pilot and definitive phase study in healthy subjects to assess the pharamcokinetics of up to three formulations of a hydromorphone/naloxone prolonged release capsule 4.8 mg and a hydromorphone prolonged release capsule 4 mg (Palladone® SR) all in a fed and fasted state.
IRAS ID
133053
Contact name
Ronnie Beboso
Contact email
Sponsor organisation
Mundipharma Research Ltd
Eudract number
2013-001860-42
Research summary
Two phase study, pilot and definitive. \nPilot: Open-label, single-dose, partially randomised, three-groups, four-period study in healthy volunteers aged 18 to 45. \nDefinitive: Two, 2-part, single-dose, open-label, randomised, crossover studies. \nThe pilot phase will consist of three groups of 4 study periods, and the definitive phase will consist of two groups of two study periods. \nIn the pilot phase (groups 1-3), Study Periods 1 and 2, subjects will be randomised to receive 3 different hydromorphone hydrochloride containing prolonged release capsules in a fasted state and Palladone®-SR prolonged release capsule (PR4) in a fasted state. \nFollowing the PK data review after period 2, one, two or three suitable formulations (PR1, PR2 or PR3) will be selected to be randomised in Study Periods 3 & 4 in the fed state vs Palladone-SR fed. If a suitable formulation cannot be identified, Study Periods 3 & 4 will not proceed as planned. \nAfter Study Period 4 all data will be reviewed to assess comparability with the reference treatment and to determine formulation selection for dosing in the definitive phase of the study. \nDefinitive phase; Group 1 subjects will participate in two study periods and receive the study drug as a prolonged release capsule formulations ; PR1, PR2 or PR3 in a fasted state and Palladone®-SR prolonged release capsule (PR4) in a fasted state. \nGroup 2 subjects will participate in two study periods and receive the study drug as a prolonged release capsule formulations; PR1, PR2 or PR3 in a fed state and Palladone®-SR 4 mg prolonged release capsule (PR4) in a fed state. \nPilot phase will enrol 48 subjects, definitive phase will enrol 100 subjects. Total duration for participation for each phase will be 30 days.\n
REC name
HSC REC A
REC reference
13/NI/0085
Date of REC Opinion
8 Jul 2013
REC opinion
Further Information Favourable Opinion