A COMPARISON BETWEEN TWO BUPRENORPHINE TABLETS AND THE EFFECT OF FOOD

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, THREE-WAY, RANDOMISED, CROSS-OVER STUDY OF THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF THE TWO FORMULATIONS OF RBP-6300 10 MG IN HEALTHY VOLUNTEERS UNDER A NALTREXONE BLOCK IN THE PRESENCE AND ABSENCE OF FOOD

• IRAS ID

  111802

• Contact name

  Simon Singer

• Sponsor organisation

  Reckitt Benckiser Pharmaceuticals Inc.

• Eudract number

  2012-002408-42

• ISRCTN Number

  xx

• Research summary

  48 male and female subjects will each receive three 10 mg doses of RBP-6300 over three treatment periods. The main aims of the study are to learn about and compare the rate of drug absorption and the subsequent blood levels observed after dosing with two different formulations of RBP-6300 (buprenorphine hemiadipate hydrochloride/naloxone hydrochloride dihydrate) in healthy males and females, with and without food. Following screening, subjects will be admitted to the CPU Day -1 of each treatment period where they will remain resident until the morning of Day 5. The subjects will then make visits in the morning of Days 6 and 7 to have blood samples taken. All doses of RBP-6300 will be administered on the morning of Day 1 of each treatment period. A post-study medical visit will be performed 5-10 days after the last PK blood sample.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/1286

• Date of REC Opinion

  29 Nov 2012

• REC opinion

  Further Information Favourable Opinion