Evaluation of Different Dwell Times on a Fentanyl Tablet

• Research type

  Research Study

• Full title

  A 4-Period, 5-Treatment, Crossover, Single-Dose Comparative Study to Evaluate the Impact of Different Dwell Times on the Bioavailability of Fentanyl Ethypharm 133 µg Buccal Tablet in Healthy Volunteers in the Fasting State

• IRAS ID

  75782

• Contact name

  Johnston Stewart

• Sponsor organisation

  ETHYPHARM

• Eudract number

  2011-000743-25

• Research summary

  This study involves a new buccal tablet formulation of fentanyl. The amount of and rate at which fentanyl from this new buccal tablet formulation gets into and is removed from the body will be assessed for four different dwell times and when leaving the buccal tablet to dissolve completely before swallowing.The aim is find a dwell time that allows a comparable amount of fentanyl to get into the blood stream at the same rate as when the buccal tablet is completely dissolved before swallowing. Volunteers will complete 4 of the 5 evaluations being conducted, receiving a single dose of the new buccal tablet formulation on 4 separate occasions. All volunteers will take part in the complete dissolution evaluation and 3 out of the 4 different dwell time evaluations. There will be an interval of at least 7 days between each of the four 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) will take part in this study at one centre in the UK.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0013

• Date of REC Opinion

  11 Apr 2011

• REC opinion

  Further Information Favourable Opinion