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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Mental Disorders

Intervention / Treatment
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* Drug: Lamotrigine IR tablets
* Drug: Lamotrigine ODT tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects in Treatment regimen C<br>Subjects in treatment regimen C will receive 200 milligram (mg) orally disintegrating tablets (ODT) of lamotrigine disintegrate in mouth without water in fasting condition. | Drug: Lamotrigine ODT tablets<br>* Lamotrigine ODT tablets will be available in dose strength of 200 mg.<br>|
| Experimental: Subjects in Treatment regimen D<br>Subjects in treatment regimen D will receive 200 mg Immediate Release (IR) tablets of lamotrigine with water in fasting condition. | Drug: Lamotrigine IR tablets<br>* Lamotrigine IR tablets will be available in dose strength of 200 mg.<br>* Other names: Lamotrigine;|
| Experimental: Subjects in Treatment regimen E<br>Subjects in treatment regimen E will receive 200 mg ODT disintegrate of lamotrigine in mouth without water in fed state. | Drug: Lamotrigine ODT tablets<br>* Lamotrigine ODT tablets will be available in dose strength of 200 mg.<br>|
| Experimental: Subjects in Treatment regimen F<br>Subjects in treatment regimen F will receive 200 mg ODT of lamotrigine, that subjects will swallow with water in fasting condition. | Drug: Lamotrigine ODT tablets<br>* Lamotrigine ODT tablets will be available in dose strength of 200 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Food effect, Safety, Tolerability, Water effect