An Open-label, Randomised, Single-dose, Parallel-group Study to Evaluate the Pharmacokinetic Characteristics, Safety and Tolerability of up to Two Formulations (With Different Taste Masking Approaches) of an Orally Disintegrating Tablet (ODT) of Lamotrigine at 25mg and 200mg Versus the Immediate Release (IR) Lamotrigine in Healthy Subjects

GlaxoSmithKline1 site in 1 country96 target enrollmentDecember 28, 2006

ConditionsMental Disorders

InterventionsLamotrigine GI267119

DrugsLamotrigine GI267119

Overview

Phase: Phase 1
Intervention: Lamotrigine
Conditions: Mental Disorders
Sponsor: GlaxoSmithKline
Enrollment: 96
Locations: 1
Primary Endpoint: Lamotrigine AUC(0-inf) and Cmax
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 28, 2006

End Date

January 25, 2007

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

GI267119

25 mg ODT tablet strength

Intervention: Lamotrigine

GI267119

25 mg ODT tablet strength

Intervention: GI267119

Outcomes

Primary Outcomes

Lamotrigine AUC(0-inf) and Cmax

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

tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points(throughout study)