Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

• Status: Completed
• Trial end date: 2007-01-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Anticonvulsants; Lamotrigine

Criteria

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