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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

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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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Jan 2021

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At a glance

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

    • Most Recent Events

    • 08 Dec 2020 Results of pooled analysis from ctp:250913 and 291633 presented at the 74th Annual Meeting of the American Epilepsy Society
    • 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.

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