TO COMPARE TWO DRUG FORMULATIONS CONTAINING BUPRENORPHINE AND NALOXONE

• 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) 2mg/0.5 mg Sublingual Tablets Plus One EU Suboxone® (Buprenorphine/Naloxone) 8mg/2mg Sublingual Tablet (Reference) Under fasted conditions

• IRAS ID

  120182

• Contact name

  Simon L Singer

• Sponsor organisation

  Reckitt Benckiser Pharmaceutical Inc.

• Eudract number

  2012-004198-23

• ISRCTN Number

  to be registered

• Research summary

  48 male and female subjects will each receive one single 12 mg sublingual tablet (12 mg buprenorphine and 3 mg naloxone) and one Suboxone© 8 mg sublingual tablet (8 mg buprenorphine and 2 mg naloxone) plus two Suboxone© 2 mg sublingual tablets (2 mg buprenorphine and 0.5 mg naloxone) over two treatment periods. The main aims of the study are to compare the rate of drug absorption and the subsequent blood levels observed after dosing with two different formulations of buprenorphine and naloxone. Following screening, subjects will be admitted to the CPU on Day 0 of each treatment period where they will remain resident until the morning of Day 7. All doses of study medication and Suboxone© will be administered on the morning of Day 1 of each treatment period. Day 7 of the second study period will be classed as the end-of-study visit.

• REC name

  Wales REC 2

• REC reference

  12/WA/0378

• Date of REC Opinion

  17 Dec 2012

• REC opinion

  Favourable Opinion