Bioavailability Study of Two Fentanyl Formulations

• Research type

  Research Study

• Full title

  A Pivotal, Two-Way, Cross-over, Single-Dose, Comparative Bioavailability Study of Fentanyl Ethypharm 133 µg Buccal Tablet and Actiq® 200 µg Fentanyl Tablet with Buccal Applicator in Healthy Volunteers in the Fasting State

• IRAS ID

  49833

• Contact name

  Johnston Stewart

• Sponsor organisation

  ETHYPHARM

• Eudract number

  2010-019045-26

• Research summary

  The purpose of this study is to compare a new fentanyl buccal tablet with the currently marketed Actiq© fentanyl lozenge. This study will find out how much of and the rate at which fentanyl gets into and is removed from the body from each of the 2 formulations. To investigate this, volunteers will receive a single dose of each of the 2 formulations in a random order on 2 separate occasions (i.e. 2 assessment periods) during the study. There will be an interval of at least 7 days between the two doses. Before initial fentanyl administration, volunteers will undergo a test to see if they tolerate opiates. Volunteers demonstrating intolerance to opiates will be excluded from taking part in this study. Male and/or female volunteers (aged between 18-55 years), split into 2 groups of approximately equal size, will take part in this study at one centre in the UK.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/6

• Date of REC Opinion

  21 Apr 2010

• REC opinion

  Further Information Favourable Opinion