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

GlaxoSmithKline220 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Mental Disorders

Interventions

Lamotrigine IR tabletsDRUG

Lamotrigine IR tablets will be available in dose strength of 200 mg.

Lamotrigine ODT tabletsDRUG

Lamotrigine ODT tablets will be available in dose strength of 200 mg.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Dallas, Texas, United States

Outcomes

Primary Outcomes

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 frame: 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 Outcomes

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.

Time frame: Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above

Data from ClinicalTrials.gov

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