NCT00449774

Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers

An Open-label, Randomised, Single-dose, Parallel-group Study to Demonstrate Bioequivalence of Two Formulations and the Effect of Food and Water on One Formulation of Lamotrigine in Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers

Conditions

• Mental Disorders

Interventions

Type	Name	Description
DRUG	Lamotrigine IR tablets	Lamotrigine IR tablets will be available in dose strength of 200 mg.
DRUG	Lamotrigine ODT tablets	Lamotrigine ODT tablets will be available in dose strength of 200 mg.

Timeline

• Start date: 2007-05-07
• Primary completion: 2007-06-19
• Completion: 2007-06-19
• First posted: 2007-03-21
• Last updated: 2017-08-08

Locations

1 site across 1 country: United States