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

NCT00449774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2017-08-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-07
Primary Completion
2007-06-19
Completion
2007-06-19

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00449774 on ClinicalTrials.gov