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

Completed · Phase 1

Conditions studied: Mental Disorders

In brief

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

Key facts

Study ID

NCT00449774

Run by

GlaxoSmithKline

People needed

220

Starts

2007-05-07

Expected to finish

2007-06-19

Last updated by the study team

2017-08-08

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or female subjects aged 19 to 55 years inclusive
• BMI within the range 19 to 32 kg/m2 inclusive.

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.