Fasted BE study of two buprenorphine(12mg)/naloxone(3mg) treatments

• Research type

  Research Study

• Full title

  A Randomized, Single-Dose, Two-Way Crossover Open Label Bioequivalence Study Comparing a Buprenorphine/Naloxone 12 mg/3 mg Tablet (Test) with two EU Suboxone® (Buprenorphine/Naloxone) 2 mg/0.5 mg Sublingual Tablets Plus One EU Suboxone® (Buprenorphine/Naloxone) 8 mg/2 mg Sublingual Tablet (Reference) Under Fasted Conditions

• IRAS ID

  137277

• Contact name

  Adrian Stewart

• Contact email

  adrian.stewart@celerion.com

• Sponsor organisation

  Reckitt Benckiser Pharmaceuticals Inc.

• Eudract number

  2012-004198-23

• ISRCTN Number

  To be registered

• REC name

  Wales REC 1

• REC reference

  13/WA/0258

• Date of REC Opinion

  13 Sep 2013

• REC opinion

  Further Information Favourable Opinion