Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Mental Disorders

Treatments

Drug: GI267119

Drug: Lamotrigine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00410371

LBI108614

Details and patient eligibility

About

This study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers

Enrollment

96 patients

Sex

All

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 to 30 kg/m2 inclusive.

Exclusion criteria

Female subjects of childbearing potential will not be eligible to participate 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 (positive serum human chorionic gonadotrophin (hCG) test at Screening and pre-dose to the study) 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
Current smokers of 10 or more cigarettes per day