Skip to main content
OpenTrials
Completed

NCT Number: NCT00449774

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mental Disorders

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lamotrigine IR tablets

Drug

Lamotrigine IR tablets will be available in dose strength of 200 mg.

Other names: Lamotrigine

Lamotrigine ODT tablets

Drug

Lamotrigine ODT tablets will be available in dose strength of 200 mg.

Primary outcomes

  1. Lamotrigine AUC(0-inf) and Cmax. Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours

    Time frame: Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours

Secondary outcomes

  1. Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above. Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate at various times during the study.

    Time frame: Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-label, Randomised, Single-dose, Parallel-group Study to Demonstrate Bioequivalence of Two Formulations and the Effect of Food and Water on One Formulation of Lamotrigine in Healthy Male and Female Volunteers

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 21, 2007
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.