To investigate bioavalability of rufinamide (E2080)

• Research type

  Research Study

• Full title

  A randomized, open label, 4-period crossover trial to compare the bioavailability of single 400 mg doses of rufinamide (E2080) administered as the marketed tablet with three suspension formulations manufactured using different homogeneity speeds

• IRAS ID

  19323

• Sponsor organisation

  Eisai Limited

• Eudract number

  2009-010271-25

• ISRCTN Number

  xx

• Research summary

  Rufinamide is the drug being tested in this study.This will not be the first time this drug has been given to human volunteers.It is currently licensed for the treatment of a special type of epilepsy that starts during childhood called Lennox-Gastaut syndrome (LGS).There will be a total of 24 healthy male or female subjects aged 18 to 55 years enrolled in this study to ensure 20 subjects complete the study. The study will involve four admission periods, each of five days (four nights) separated by approximately 5 to 7 days. The follow up will be 1 - 3 weeks after the last dose. The maximum amount of time the volunteers involved in the study will be 12 weeks.Volunteers will receive 3 different formulations of rufinamide as well as receiving the marketed product.The purpose of this study is to examine the way the body absorbs the 3 new liquid formulations of rufinamide when compared with the marketed tablets of the same dose in healthy volunteers. The information gained in this study will help the sponsor of this study to determine whether the different formulations of Rufinamide produce the same effect as the marketed tablet.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/50

• Date of REC Opinion

  6 Apr 2009

• REC opinion

  Favourable Opinion