PK Study of Buprenorphine Skin Patches (QBR117374)
Research type
Research Study
Full title
A four-period, randomised, open-label, crossover, pharmacokinetic study to assess the dose proportionality and relative bioavailability of Buprenorphine Transdermal Delivery System second generation patches compared to first generation patches, in healthy volunteers.
IRAS ID
154541
Contact name
Joanne Collier
Contact email
Sponsor organisation
Mundipharma Research Limited
Eudract number
2014-000691-26
ISRCTN Number
To be registered
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 pain conditions.\nThe purpose of the study is to obtain data on the speed of release of the study drug from 2nd generation patches and the availability of the study drug to the body compared to 1st generation patches.\nThe study will consist of 4 study periods involving approximately 20 healthy male and female subjects. Subjects will be administered each of the following 4 treatments, with a minimum of 10 days between removal of one patch and application of another. \n-2nd Generation Patch 12.6mg (anticipated release rate 20 µg/h over 7 days)\n-2nd Generation Patch 3.15mg (anticipated release rate 5 µg/h over 7 days)\n-BuTrans 20mg (1st Generation Patch; 20 µg/h over 7 days)\nBuTrans 5mg (1st Generation Patch; 5 µg/h over 7 days)\n
REC name
Wales REC 1
REC reference
14/WA/0155
Date of REC Opinion
9 May 2014
REC opinion
Further Information Favourable Opinion