Conditions: Epilepsy
Allocation: NON_RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 4
Healthy volunteers: no

Brief summary:
The prior BEEP study involved patients being switched between brand and generic in a very structured manner. Other secondary comparisons were also made (i.e. any differences in adverse effects and seizure control). Some subjects were more disparate than other, in terms of generic being similar to brand. In this follow up study, BEEP subjects that showed disparate results will be tested again to assess reproducibility of disparate results.

Detailed description:
This is an double-blind, multiple-dose, full replicate design, pharmacokinetic study of lamotrigine in "enriched" patients with epilepsy who previously participated in HP-00048923. LAMICTAL 100mg tablets and the most commonly used generic lamotrigine 100mg tablet (from Teva) will be compared pharmacokinetically.

Arms:
arm 1: lamotrigine tablet Lamictal arm 2: lamotrigine tablet Teva arm 3: lamotrigine tablet Lamictal arm 4: lamotrigine tablet Teva

Interventions: intervention 1: lamotrigine (brand Lamictal) intervention 2: lamotrigine (generic Teva)
Intervention descriptions: intervention 1: an anti-epileptic drug (brand) intervention 2: an anti-epileptic drug (brand)

Protocol document: