Conditions: Epilepsy
Keywords: bioequivalence lamotrigine epilepsy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 35
Healthy volunteers: no

Brief 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.

Detailed description:
As is commonly done in a bioequivalence study, the null hypothesis is that the generic (i.e. test) is bioINequivalent to the brand name (i.e. reference). Hence, the alternative hypothesis is that the generic is bioequivalent to the brand name.

Arms:
arm 1: Crossover trial. Each arm will receive Brand lamotrigine tablet for two periods and Generic lamotrigine for two periods. arm 2: Crossover trial. Each arm will receive Generic lamotrigine tablet for two periods and Brand lamotrigine for two periods.

Interventions: intervention 1: Brand lamotrigine intervention 2: Generic lamotrigine
Intervention descriptions: intervention 1: Brand lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks intervention 2: Generic lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks

Protocol document: