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This study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GI267119 | Experimental | 25 mg ODT tablet strength |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamotrigine | Drug | Lamotrigine |
| |
| GI267119 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points | throughout study |
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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 | Lincoln | Nebraska | 68502 | United States |
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| 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 |
| Results for study LBI108614 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| LBI108614 | Informed Consent Form | 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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| Drug |
25 mg ODT |
|
For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108614 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108614 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108614 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108614 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108614 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LBI108614 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |