A PK Assessment of 4 Buprenorphine 2nd Generation patches

• Research type

  Research Study

• Full title

  A 2 stage, randomised, open-label, pharmacokinetic study of relative and absolute bioavailability and dose proportionality in 4 Burprenorphine Transdermal Delivery System second generation patches.

• IRAS ID

  105263

• Contact name

  Ronnie Beboso

• Sponsor organisation

  Mundipharma Research Limited

• Eudract number

  2012-002185-12

• Research summary

  The aim of the study is to compare 4 new formulation buprenorphine patches with the existing marketed patch formulation. If the study is successful at Stage 1, the patch selected for further development at Stage 2 will contain a significantly lower overall buprenorphine content than the exisiting patch, but still release the same amount over 7 days. This will increase safety, reduce environmental impact and reduce the cost of the product. Stage 2 will not proceed if Stage 1 is unsuccessful. This randomised, open-label, 2-stage pharmacokinetic study in healthy males & females will use a similar design to previous PK studies for Buprenorphine Transdermal Delivery System Treatment (BTDS). The study will consist of BTDS patches (existing and second generation) and a Buprenorphine Intravenous Infusion (BIV). In Stage 1 each volunteer will receive the reference patch (BTDS 20ug/h) and 3 out of the 4 test patches. In Stage 2 treatments will include the successful patch from Stage 1, a 1/4 size successful Stage 1 patch and a BIV infusion for 24 hours. Volunteers will be randomised to both the order and patch site of the 4 treatments to be delivered over 4 study periods. Patches will be applied for 7 days, the BIV infusion will run over a 24 hour period. The study will enrol healthy males and females aged 18 to 55. Approximately 52 randomised into Stage 1 to complete 44. If Stage 2 proceeds, it will randomise 40 for 33 to complete. The exact number will be calculated after Stage 1. Approximately 92 will be randomised in total. Duration of the study - up to 69 days for Stage 1, the same for Stage 2 (excludes screening).

• REC name

  HSC REC B

• REC reference

  12/NI/0109

• Date of REC Opinion

  6 Aug 2012

• REC opinion

  Further Information Favourable Opinion