Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

This study has been completed.

First Received: December 11, 2006 Last Updated: October 15, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00410371

Purpose

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

Condition	Intervention	Phase
Healthy Subjects	Drug: Lamotrigine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Randomised, Single-Dose, Parallel-Group Study to Compare the Pharmacokinetic Characteristics, Safety and Tolerability of Two Formulations of Lamotrigine in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Lamotrigine AUC(0-O) 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

Secondary Outcome Measures:

tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate Time points: throughout study

Estimated Enrollment:	96
Study Start Date:	December 2006

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410371

Locations

United States, Nebraska
GSK Investigational Site
Lincoln, Nebraska, United States, 68502

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	LBI108614
Study First Received:	December 11, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00410371 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Pharmacokinetic characteristics
safety
tolerability

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Lamotrigine
Calcium Channel Blockers

Cardiovascular Agents
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009