Dose Proportionality Study of Fentanyl Buccal Tablets
Research type
Research Study
Full title
A Pivotal, Three-Way Cross-over, Single-Dose, Dose-Proportionality Study of Fentanyl Ethypharm Buccal Tablets in Healthy Volunteers in the Fasting State
IRAS ID
49610
Contact name
Johnston Stewart
Contact email
Sponsor organisation
ETHYPHARM
Eudract number
2010-019044-39
Research summary
The purpose of this study is to compare 3 different strengths of a new fentanyl buccal tablet. This study will find out how much of and the rate at which fentanyl gets into and is removed from the body at each strength. The aim is to show that the amount of fentanyl that gets into the body at the 3 different dose levels is proportional – i.e. the blood levels of fentanyl increase in the same degree as the dose.
To investigate this, volunteers will receive a single dose of each of the 3 tablet strengths in a random order on 3 separate occasions (i.e. 3 assessment periods) during the study. There will be an interval of at least 14 days between the doses in each period.
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/IEC02/5
Date of REC Opinion
21 Apr 2010
REC opinion
Further Information Favourable Opinion