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Lamotrigine IR

Phase 1

Mental Disorders | Small molecule | Psychiatry |GSK plc|Last Updated: Aug 8, 2017

Target and mechanism

ModalitySmall molecule

Also known as Lamotrigine IR tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

Clinical trial landscape

Lamotrigine IR · 1 trial · 1 indication

Phase 1 1
NCT00449774Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy VolunteersMental Disorders
COMPLETED220 Analytics
PHASE1COMPLETED
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
Mental Disorders
NCT00449774220
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Study Endpoints

Primary Endpoints

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 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 Endpoints

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.
Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects in Treatment regimen CEXPERIMENTALSubjects in treatment regimen C will receive 200 milligram (mg) orally disintegrating tablets (ODT) of lamotrigine disintegrate in mouth without water in fasting condition.
Subjects in Treatment regimen DEXPERIMENTALSubjects in treatment regimen D will receive 200 mg Immediate Release (IR) tablets of lamotrigine with water in fasting condition.
Subjects in Treatment regimen EEXPERIMENTALSubjects in treatment regimen E will receive 200 mg ODT disintegrate of lamotrigine in mouth without water in fed state.
Subjects in Treatment regimen FEXPERIMENTALSubjects in treatment regimen F will receive 200 mg ODT of lamotrigine, that subjects will swallow with water in fasting condition.

Interventions

NameTypeDescription
Lamotrigine IR tabletsDRUGLamotrigine IR tablets will be available in dose strength of 200 mg.
Lamotrigine ODT tabletsDRUGLamotrigine ODT tablets will be available in dose strength of 200 mg.
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Eligibility Criteria

Age Range19 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 a...

Countries:United States
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Competitive Landscape -Mental Health Disorders 10 trials (matched to "Mental Disorders")

No competing companies are currently tracked in active development for Mental Health Disorders.
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