Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

Study Overview
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Brief Summary
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This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers

Official Title
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A Pivotal Single-dose Randomised, Parallel-group, Open-label Study to Demonstrate Bioequivalence of 300mg Lamotrigine XR Relative to 100mg + 200mg Lamotrigine XR and to Demonstrate Lack of Food Effect on 300mg Lamotrigine XR in Healthy Male and Female Volunteers

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Lamotrigine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 - 29.9 kg/m2 inclusive. Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, vital signs and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures. Exclusion Criteria: Female subjects of childbearing potential will not be eligible to participate who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria from at least the commencement of their last normal period prior to the first dose of study medication; and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 5 half lives of the study medication, whichever is the longest. Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at screening) or lactating. Female subjects using hormonal contraceptive precautions including progesterone-coated IUD Female subjects using hormonal replacement therapy. Subjects who received lamotrigine in a previous study (subjects who received placebo will be allowed). Current smokers of 10 or more cigarettes per day.

Ages Eligible for Study
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Minimum Age: 18 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 A<br>Subjects in treatment regimen A will receive 100 and 200 mg lamotrigine XR in fasting condition. | Drug: Lamotrigine<br>* In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.<br>|
| Experimental: Subjects in treatment regimen B<br>Subjects in treatment regimen B will receive 100 mg lamotrigine XR in fasting condition. | Drug: Lamotrigine<br>* In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.<br>|
| Experimental: Subjects in treatment regimen C<br>Subjects in treatment regimen C will receive 100 mg lamotrigine XR in fed condition. | Drug: Lamotrigine<br>* In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics ie Serum lamotrigine Cmax and AUC(0-inf) |  | taken pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 36, 48, 72, 96, 120 and 144 hours following dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK (AUC (0-t), tmax and t1/2 ) |  | taken pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 36, 48, 72, 96, 120 and 144 hours following dosing | 
| safety and tolerability based on physical exam, adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate measure |  | at Screening, Day -1, Day 1, Day 2 and follow up 7-14 days after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers, bioequivalence, food effects