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BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients

Epilepsy Clinical Trial

Official title:
Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02404168
Study type Interventional
Source University of Maryland, Baltimore
Contact
Status Completed
Phase Phase 4
Start date July 7, 2015
Completion date April 6, 2016
View Details
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