Comparison Study of Two Buprenorphine Sublingual Tablets

• Research type

  Research Study

• Full title

  Comparative, Randomised, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group PTC ehf and Schering-Plough Ltd (Subutex®) 0.4 mg Buprenorphine Sublingual Tablets in Healthy Adult Volunteers under Fasting Conditions

• IRAS ID

  55586

• Contact name

  Johnston Stewart

• Sponsor organisation

  Actavis Group PTC ehf

• Eudract number

  2010-020750-34

• Research summary

  The purpose of this study is to compare a new buprenorphine sublingual tablet with the currently marketed buprenorphine sublingual tablet, Subutex©. This study will find out how much of and the rate at which buprenorphine gets into and is removed from the body from each of the 2 formulations. To investigate this, volunteers will receive a single dose of each of the formulations in a random order on 2 separate occasions (i.e. 2 assessment periods) during the study. There will be an interval of at least 21 days between the two doses. Before initial buprenorphine administration, volunteers will undergo a test to see if they tolerate opiates. Volunteers demonstrating intolerance to opiates will be excluded from taking part in this study. Male and/or female volunteers (aged between 18-55 years), split into 2 groups of approximately equal size; will take part in this study at one centre in the UK.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/15

• Date of REC Opinion

  15 Jun 2010

• REC opinion

  Further Information Favourable Opinion