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

• Status: Completed
• Trial end date: 2007-06-19
• Target enrollment: 0
• Participant gender: All

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

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Anticonvulsants; Lamotrigine

Criteria

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