Levetiracetam in healthy male & female Japanese subjects

• Research type

  Research Study

• Full title

  Randomized, monocenter, open label, two-way cross-over, single dose bioequivalence study of two different formulations of levetiracetam in healthy male & female Japanese subjects.

• IRAS ID

  27299

• Contact name

  Daryl Bendel

• Sponsor organisation

  UCB Pharma SA

• Eudract number

  2009-011358-16

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to compare 2 formulations of one drug (Levetiracetam). Levetiracetam is currently available on the market worldwide for the treatment of epilepsy and is available in tablet form (it is also available for injection). A dry syrup formulation has been developed for use in Japan in patients who have difficulty swallowing tablets, in particular for children. This study investigates the bioequivalence between the dry syrup formulation (new formulation) and the tablets (reference formulation).

• REC name

  London - Brent Research Ethics Committee

• REC reference

  09/H0717/50

• Date of REC Opinion

  3 Aug 2009

• REC opinion

  Favourable Opinion