Proportionality, Bioavailablity and Flux of Buprenorphine

• Research type

  Research Study

• Full title

  A randomised, phase 1, open-label, single-dose, seven treatment, four part crossover, incomplete block study in healthy subjects to determine the dose proportionality, absolute bioavailability and flux of buprenorphine delivered by a transdermal system

• IRAS ID

  27741

• Eudract number

  2009-012101-18

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  The study treatment, BuTrans©, is already on the market in the UK to treat the severe pain associated with chronic osteoarthritis. The sponsor company also has a product on the market in Germany called Transtec©. BuTrans© and Transtec© are both patches that contain buprenorphine, which belongs to a group of drugs called opiods. The patches are designed to be applied to the skin and worn for a continuous period of 7 days(Butrans) or 4 days (Ttantec). The sponsor company are looking into new patch strengths of 15 æg/h, 25 æg/h, 30 æg/h, and 40 æg/h. This means that 15, 25, 30 and 40 micrograms of buprenorphine are released into the body every hour whilst the patch is being worn. The sponsor company also has buprenorphine as an injection on the market, in the US this product is called Buprenex© and in the UK as Temgesic©; both are available in a strength of 300 æg/h. This drug can be used for moderate to severe pain. During the study the volunteers will be allocated to receive either buprenorphine patches (BTDS) or buprenorphine as an infusion, which means the drug will be injected into a vein using a pump (BIV)by chance. Volunteers may receive BTDS 4 times or BTDS 3 times plus BIV once. Naltrexone is already on the market, and can be used to block the action of opiod drugs. During this study it will be given to reduce the side effects of buprenorphine. Volunteers participating in the study involving visits to LCG Bioscience will be about 58 days over the course of 12 - 16 weeks.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  09/H0304/56

• Date of REC Opinion

  18 Aug 2009

• REC opinion

  Further Information Favourable Opinion