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

Tracking Information

First Received Date ^ICMJE

March 19, 2007

Last Updated Date

May 15, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00449774 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Bio-equivalence Study

Condition ^ICMJE

Healthy Subjects

Intervention ^ICMJE

Drug: Lamotrigine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

220

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00449774

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

LBI108617

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MRCP, FFPM

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP