A Pivotal, Single-Dose, Randomised, Parallel-Group, Open-Label Study to Demonstrate Bioequivalence of 250mg Lamotrigine XR 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 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: 14 Sep 2017

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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