Study to Compare Two Formulations of Lamotrigine in Healthy Subjects - Tabular View

Tracking Information

First Received Date ^ICMJE

December 11, 2006

Last Updated Date

October 15, 2008

Start Date ^ICMJE

December 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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
Lamotrigine AUC(0-O) and Cmax for each of the ODT tablets and the corresponding IR comparator

Change History

Complete list of historical versions of study NCT00410371 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

tmax and t½ for each of the ODT tablets and the corresponding IR comparator
Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate
Time points: as for primary outcome

Descriptive Information

Brief Title ^ICMJE

Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

Official Title ^ICMJE

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

Brief Summary

This study intends to compare the pharmacokinetic characteristics, 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, Pharmacokinetics 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

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

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

NCT00410371

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

LBI108614

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

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