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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Mental Disorders

Treatments: Drug: Lamotrigine IR tablets; Drug: Lamotrigine ODT tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00449774

LBI108617

Details and patient eligibility

About

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

Enrollment: 220 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 4 patient groups

Subjects in Treatment regimen C

Experimental group

Description:

Subjects in treatment regimen C will receive 200 milligram (mg) orally disintegrating tablets (ODT) of lamotrigine disintegrate in mouth without water in fasting condition.

Treatment:

Drug: Lamotrigine ODT tablets

Subjects in Treatment regimen D

Experimental group

Description:

Subjects in treatment regimen D will receive 200 mg Immediate Release (IR) tablets of lamotrigine with water in fasting condition.

Treatment:

Drug: Lamotrigine IR tablets

Subjects in Treatment regimen E

Experimental group

Description:

Subjects in treatment regimen E will receive 200 mg ODT disintegrate of lamotrigine in mouth without water in fed state.

Treatment:

Drug: Lamotrigine ODT tablets

Subjects in Treatment regimen F

Experimental group

Description:

Subjects in treatment regimen F will receive 200 mg ODT of lamotrigine, that subjects will swallow with water in fasting condition.

Treatment:

Drug: Lamotrigine ODT tablets