Fasted BE study of three buprenorphine(16mg)/naloxone(4mg) treatments

• Research type

  Research Study

• Full title

  A Randomized, Single-Dose, Three-Way Crossover Open Label Bioequivalence Study Comparing a Buprenorphine/Naloxone 16 mg/4 mg tablet (Hexagonal) (Treatment A), a Buprenorphine /Naloxone 16 mg/4 mg tablet (Circular) (Treatment B) with two EU Suboxone® (Buprenorphine /Naloxone) 8 mg/2 mg Sublingual Tablet (Treatment C: Reference) under Fasted Conditions

• IRAS ID

  138512

• Contact name

  Adrian Stewart

• Contact email

  adrian.stewart@celerion.com

• Sponsor organisation

  Reckitt Benckiser Pharmaceuticals Ltd.

• Eudract number

  2012-004199-20

• ISRCTN Number

  To be registered

• REC name

  Wales REC 1

• REC reference

  13/WA/0259

• Date of REC Opinion

  13 Sep 2013

• REC opinion

  Further Information Favourable Opinion