Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00449774

Purpose

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

Condition	Intervention	Phase
Healthy Subjects Mental Disorders	Drug: Lamotrigine	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Psychotic Disorders

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Outcome Measures:

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 ]

Enrollment:	220
Study Start Date:	May 2007

Intervention Details:

Other Name: Lamotrigine

Eligibility

Ages Eligible for Study:	19 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449774

Locations

United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75247

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MRCP, FFPM

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00449774 History of Changes
Other Study ID Numbers:	LBI108617
Study First Received:	March 19, 2007
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Food effect
Safety
Tolerability
Water effect
Bioequivalence

Additional relevant MeSH terms:

Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Lamotrigine
Calcium Channel Blockers
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012