A pivotal single-dose randomised, parallel-group, open-label study to demonstrate bioequivalence of 300mg lamotrigine XR [extended release] relative to 100mg + 200mg lamotrigine XR and to demonstrate lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers.

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Trial Profile

A pivotal single-dose randomised, parallel-group, open-label study to demonstrate bioequivalence of 300mg lamotrigine XR [extended release] relative to 100mg + 200mg lamotrigine XR and to demonstrate lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers.

Completed
Phase of Trial: Phase I

Latest Information Update: 09 Aug 2017

At a glance

  • Drugs Lamotrigine (Primary)
  • Indications Epilepsy
  • Focus Pharmacokinetics; Registrational
  • Sponsors GlaxoSmithKline

    • Most Recent Events

    • 04 Jan 2007 New trial record.
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