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

Phase 1

Completed

• Conditions: Mental Disorders
• Interventions: Drug: Lamotrigine ODT tablets; Drug: Lamotrigine IR tablets

• Registration Number: NCT00449774
• Lead Sponsor: GlaxoSmithKline

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-19
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-21
• Study Start: 2007-05-07
• Primary Completion: 2007-06-19
• Study Completion: 2007-06-19
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-05
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Healthy male or female subjects aged 19 to 55 years inclusive
• BMI within the range 19 to 32 kg/m2 inclusive.

Exclusion Criteria

• Female subjects of childbearing potential will not be eligible if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.
• Female subject is pregnant or lactating.
• Female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (IUD).
• Female subjects using hormonal replacement therapy.
• History of regular alcohol consumption > 7 drinks week for women and 14 drinks week for men
• Current smokers of 10 or more cigarettes per day

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects in Treatment regimen C	Lamotrigine ODT tablets	Subjects in treatment regimen C will receive 200 milligram (mg) orally disintegrating tablets (ODT) of lamotrigine disintegrate in mouth without water in fasting condition.
Subjects in Treatment regimen E	Lamotrigine ODT tablets	Subjects in treatment regimen E will receive 200 mg ODT disintegrate of lamotrigine in mouth without water in fed state.
Subjects in Treatment regimen F	Lamotrigine ODT tablets	Subjects in treatment regimen F will receive 200 mg ODT of lamotrigine, that subjects will swallow with water in fasting condition.
Subjects in Treatment regimen D	Lamotrigine IR tablets	Subjects in treatment regimen D will receive 200 mg Immediate Release (IR) tablets of lamotrigine with water in fasting condition.

Primary Outcome Measures

Name	Time	Method
Lamotrigine AUC(0-inf) and Cmax. Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours	Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours

Secondary Outcome Measures

Name	Time	Method
Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above. Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate at various times during the study.	Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Dallas, Texas, United States