At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Bioequivalence of Lamotrigine Tablets in Epileptic Patients
In Brief
A Phase 4 clinical trial evaluating Brand lamotrigine and Generic lamotrigine for Epilepsy. Completed, enrolled 35 participants across 1 site.
Detailed Summary
In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and patients with epilepsy have believed that brand and generic lamotrigine have had clinically significant differences in efficacy and tolerability. The brand name and generic tablets have been shown to be the same when blood levels were measured in healthy volunteers without epilepsy, but these drugs have not yet been compared in patients with epilepsy. This study will do this comparison, by switching patients between brand and generic in a very structured manner, and seeing if the drugs are the same, primarily in terms of blood levels. Other comparisons will also be made secondarily, looking for any differences in adverse effects and seizure control.
Study Details
Timeline
Interventions
Brand lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks
Generic lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks