A pivotal single-dose, randomised, parallel-group, open-label study to demonstrate bioequivalence of 250mg lamotrigine XR [extended-release] relative to 200mg + 50mg lamotrigine XR and to demonstrate lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers.

Trial Profile

A pivotal single-dose, randomised, parallel-group, open-label study to demonstrate bioequivalence of 250mg lamotrigine XR [extended-release] relative to 200mg + 50mg lamotrigine XR and to demonstrate lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers.

Completed
Phase of Trial: Phase I

Latest Information Update: 10 Nov 2016

At a glance

  • Drugs Lamotrigine (Primary)
  • Indications Epilepsy; Lennox-Gastaut syndrome; Mood disorders
  • Focus Pharmacokinetics; Registrational
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 27 Oct 2008 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 05 Mar 2008 New trial record.
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