TO COMPARE THE PROPERTIES OF THREE DIFFERENT SUBLINGUAL TABLETS

• Research type

  Research Study

• Full title

  A Randomized, Single-Dose, Three-Way Crossover Open Label Bioequivalence Study Comparing a Buprenorphine HCl/Naloxone HCl Dihydrate16 mg/4 mg tablet (Hexagonal 800mg) (Treatment A), a Buprenorphine HCl/Naloxone HCl Dihydrate 16 mg/4 mg tablet (Circular 400mg) (Treatment B) with two EU Suboxone® Tablet (Buprenorphine HCl/Naloxone HCl Dihydrate) 8 mg/2 mg tablets (reference) under Fasted Conditions

• IRAS ID

  120941

• Contact name

  Simon L Singer

• Sponsor organisation

  Reckitt Benckiser Pharmaceutical Inc.

• Eudract number

  2012-004198-20

• ISRCTN Number

  to be registered

• Research summary

  48 male and female subjects will each receive one single 16 mg sublingual hexagonal tablet (16 mg buprenorphine and 4 mg naloxone), one single 16 mg sublingual circular tablet (16 mg buprenorphine and 4 mg naloxone) and two Suboxone© 8 mg sublingual tablets over three 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/0379

• Date of REC Opinion

  17 Dec 2012

• REC opinion

  Favourable Opinion