A COMPARISON OF FOUR DIFFERENT DOSES OF BUPRENORPHINE PLUS NALOXONE

• Research type

  Research Study

• Full title

  An Open-Label, Randomised, Parallel Group, Multiple Dose, Phase I, Steady state Pharmacokinetics/Safety Comparison Study Between Oral RBP-6300 Tablets (Buprenorphine Hemiadipate Hydrochloride/Naloxone Hydrochloride Dihydrate 5/5 mg, 10/10 mg and 20/20 mg) Compared to Sublingual Suboxone® Tablets (Buprenorphine/Naloxone 8/2 mg) in Healthy Male Volunteers Under a Naltrexone Block

• IRAS ID

  62461

• Contact name

  Simon Singer

• Sponsor organisation

  Reckitt Benckiser Pharmaceuticals Inc

• Eudract number

  2010-022283-12

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Sixty subjects will receive one of three oral RBP-6300 dose levels or sublingual Suboxone©, which is the currently licensed formulation of buprenorphine/naloxone daily for 14 days. Following screening subjects will be admitted to the CPU on the morning of Day -1 where they will remain resident until the morning of Day 20. All doses will be administered under a naltrexone block, with study subjects receiving at least a 50mg daily dose of naltrexone starting on Day -1 until day 19. Subjects will have blood samples taken so that blood concentrations of drug can be measured. A follow up visit will be performed within 10 days of discharge from the CPU.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC03/19

• Date of REC Opinion

  9 Sep 2010

• REC opinion

  Further Information Favourable Opinion