QCL-105208 (E2007-E044-037)

• Research type

  Research Study

• Full title

  A randomised, open label, cross over study to demonstrate bioequivalence between 6 x 2mg tablets of Perampanel and a single 12mg tablet of Perampanel in healthy subjects

• IRAS ID

  53364

• Contact name

  Joanne Collier

• Sponsor organisation

  Eisai Ltd

• Eudract number

  2010-019700-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Perampanel is a drug that is being developed to treat a form of epilepsy. It is currently at Phase 3 of development with doses of up to 12mg being tested. Subjects have had to take multiple tablets to acheive the required dose as only 2mg and 4mg tablets are available. This study aims to investigate whether a single 12mg tablet of Perampanel is equivalent to taking six 2mg tablets.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/5

• Date of REC Opinion

  4 Jun 2010

• REC opinion

  Favourable Opinion