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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects in Treatment regimen C | Experimental | Subjects in treatment regimen C will receive 200 milligram (mg) orally disintegrating tablets (ODT) of lamotrigine disintegrate in mouth without water in fasting condition. |
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| Subjects in Treatment regimen D | Experimental | Subjects in treatment regimen D will receive 200 mg Immediate Release (IR) tablets of lamotrigine with water in fasting condition. |
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| Subjects in Treatment regimen E | Experimental | Subjects in treatment regimen E will receive 200 mg ODT disintegrate of lamotrigine in mouth without water in fed state. |
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| Subjects in Treatment regimen F | Experimental | Subjects in treatment regimen F will receive 200 mg ODT of lamotrigine, that subjects will swallow with water in fasting condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamotrigine IR tablets | Drug | Lamotrigine IR tablets will be available in dose strength of 200 mg. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Dallas | Texas | 75247 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | This study has not been published in the scientific literature. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| LBI108617 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Lamotrigine ODT tablets | Drug | Lamotrigine ODT tablets will be available in dose strength of 200 mg. |
|
| Results for study LBI108617 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108617 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108617 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108617 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108617 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108617 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108617 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |