An Assessment of Buprenorphine Transdermal System Patch Adhesion
Research type
Research Study
Full title
A two-period, randomised, open-label, crossover study to assess the adhesion of Buprenorphine Transdermal System 40 µg/h patch and 20 µg/h patch, in healthy volunteers.
IRAS ID
163319
Contact name
Paul Bailey
Contact email
Sponsor organisation
Mundipharma Research Ltd
Eudract number
2014-003421-18
Duration of Study in the UK
0 years, 3 months, 23 days
Research summary
BUP1508 is a single-dose, two-period, randomised, open-label, crossover study in healthy male and female subjects to assess the adhesion of BTDS patch 40µg/h. The purpose of the study is to provide evidence that the adhesion performance of the new BTDS patches, 15, 25, 30 and 40µg/h is comparable to the approved BTDS 5, 10 and 20µg/h patches.
Following a screening period of up to 21 days, approximately 40 healthy subjects aged 18 to 55 will be enrolled and randomised to two treatment sequences. Each will receive a patch applied for 7 days with a minimum 10 days washout between removal of one patch and application of another. Patches will be applied to the right upper back or left upper back, in a randomised order. Naltrexone will be co-administered 12-hourly to reduce opioid related AEs.
Subjects will have a post-study medical 7-10 days after their last patch removal.
The duration for each subject will be 11 days per study period to include check-in on Day -1, total duration of 2 periods to include 10 days washout period = approximately 32 days.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/0077
Date of REC Opinion
10 Feb 2015
REC opinion
Further Information Favourable Opinion