Study to compare the PK of OX219 and Suboxone
Research type
Research Study
Full title
A Phase I, open-label, randomised, 2-period cross-over study in healthy male volunteers to evaluate the pharmacokinetics, tolerability and safety of a candidate formulation of OX219 compared to Suboxone® under naltrexone block
IRAS ID
54681
Contact name
Peter Dewland
Sponsor organisation
Orexo AB (publ)
Eudract number
2010-020210-28
ISRCTN Number
NA
Research summary
The aim the study is to develop a sublingual tablet of buprenorphine and naloxone that has improved characteristics of taste and feel than the currently available standard. A faster time to disintegration is also sought as this will allow for shorter observation times of those receiving this medication. This is a single centre, open label, randomized 2-way crossover study. Each subject will participate in a screening visit, two study periods and a follow up visit. Subjects will be randomised to receive either a currently available combination of buprenorphine and naloxone, or the new investigative formulation of buprenorphine and naloxone. The two formulations will be compared by measurement of pharmacokinetic parameters up to 48hours after the dose and assessment of taste and feel of the medication. Vital signs will be measured throughout and adverse events monitored for the duration of the study. Subjects must be male, aged between 18 and 50 years inclusive with a BMI of 20.0-29.0 inclusive. They must also be negative for alcohol and drugs of abuse tests at screening and on each admission, have refrained from smoking within one month of screening visit until the completion of the study and be in good health in the opinion of the investigator. Owing to the route of dosing subjects with a current piercing of either the tongue or lip will not be eligible to take part.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
10/IEC03/15
Date of REC Opinion
24 Jun 2010
REC opinion
Further Information Favourable Opinion