Pharmacokinetic Study of Three Formulations of Lacosamide

• Research type

  Research Study

• Full title

  Single Site, Open-Label, Randomized, Single Dose, 3-Way Cross-over, Pilot Study to Compare the Pharmacokinetics of Lacosamide When Given as an Oral Modified Release or Immediate Release Tablet in 12 Healthy Male Subjects Celerion Code: AA91652

• IRAS ID

  54247

• Contact name

  Stephen Smith

• Sponsor organisation

  UCB Pharma SA

• Eudract number

  2010-018887-17

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to compare three different formulations of lacosamide to find out how much of and the rate at which lacosamide gets into and is removed from the body; and to assess if the three formulations of lacosamide are safe and tolerated. To investigate this, volunteers will receive a single dose of each of the three formulations in a random order on three separate occasions (i.e. three assessment periods) during the study. There will be an interval of at least 7 days between the three doses. Caucasian male volunteers (aged between 18-45 years) will take part in this study at one centre in the UK.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/10

• Date of REC Opinion

  1 Jul 2010

• REC opinion

  Favourable Opinion