Bioequivalence and adhesion comparison of buprenorphine patches
Research type
Research Study
Full title
A two-period, randomised open-label, crossover, pharmacokinetic study to assess the bioequivalence and adhesion of Buprenorphine Transdermal System second generation patch compared with first generation patch, in healthy volunteers.
IRAS ID
162282
Contact name
Litza McKenzie
Contact email
Sponsor organisation
Mundipharma Research Limited
Eudract number
2014-002116-17
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing a patch system to deliver the study drug, buprenorphine, through the skin for the treatment of moderate to severe pain. \n\nThe purpose of this study is to investigate how the study drug is taken up by the body using a new transdermal (absorbed through the skin) patch and how well the patch sticks to the skin will also be assessed in comparison to the reference (marketed) patch. The reference patch (1st generation BTDS) is a licensed (marketed) drug (in the UK since 2005) used to treat pain of moderate to severe intensity and is applied to the skin as a patch, similar to a plaster. \n\nThe study will consist of 2 different treatment periods, involving approximately 100 healthy adult male and female volunteers enrolled across 2 sites. The study drug will be applied to the skin as a patch and kept on for 7 successive days, with a minimum of 14 days between the removal of one patch and the application of the other. Subjects will receive both the new (2nd generation) and 1st generation patches during the study: \n- BuTrans 1st generation patch, release rate 20 µg/h \n- 2nd generation patch, target release rate 20 µg/h\n\n
REC name
Wales REC 1
REC reference
14/WA/1116
Date of REC Opinion
8 Sep 2014
REC opinion
Favourable Opinion