A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects

Trial Profile

A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 06 May 2017

At a glance

  • Drugs Perampanel (Primary)
  • Indications Epilepsy; Partial epilepsies; Tonic-clonic epilepsy
  • Focus Pharmacokinetics
  • Sponsors Eisai Inc
  • Most Recent Events

    • 06 May 2017 Primary endpoint [(Pharmacokinetics of Perampanel : Cmax (Fed condition)] has not been met, according to the Results presented at the 69th Annual Meeting of the American Academy of Neurology.
    • 06 May 2017 Primary endpoint [Pharmacokinetics of Perampanel : AUC(0-inf) (Fed condition)] has been met, according to the Results presented at the 69th Annual Meeting of the American Academy of Neurology.
    • 06 May 2017 Primary endpoint [Pharmacokinetics of Perampanel : AUC(0-t) (Fed condition)] has been met, according to the Results presented at the 69th Annual Meeting of the American Academy of Neurology.
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