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Bioequivalence and Food Effect of 250mg of Lamotrigine XR

NCT00605371 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2017-09-11

No results posted yet for this study

Summary

This study intends to demonstrate bioequivalence and lack of food effect on 250mg lamotrigine XR in healthy male and female volunteers

Conditions

Interventions

DRUG

Lamotrigine tablet

Lamotrigine extended release single dose tablet will be available with dosing strengths of 200 milligrams and 50 milligrams intended to be administered orally in fasted state. It will be a round standard convex shape tablet.

DRUG

Lamotrigine caplet

Lamotrigine extended release single dose caplet will be available with dosing strength of 200 milligrams and 50 milligrams intended to be administered orally in fasted and fed state.

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
2008-01-15
Primary Completion
2008-03-06
Completion
2008-03-06

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT00605371 on ClinicalTrials.gov