Pharmacokinetic interaction study between eslicarbazepine acetate and lamotrigine in healthy subjects
December 29th, 2009 Posted by: admin
Almeida L, Nunes T, Sicard E, Rocha J-F, Falcão A, Brunet J-S, Lefebvre M, Soares-da-Silva P. Pharmacokinetic interaction study between eslicarbazepine acetate and lamotrigine in healthy subjects.Acta Neurol Scand: DOI: 10.1111/j.1600-0404.2009.01233.x.© 2009 The Authors Journal compilation © 2009 Blackwell Munksgaard.Objective [ndash] Anti-epileptic drugs are often used in combination. Both eslicarbazepine (main metabolite of eslicarbazepine acetate, ESL) and lamotrigine undergo conjugation with glucuronic acid, and both eslicarbazepine and its glucuronide and lamotrigine glucuronide undergo extensive renal elimination; therefore, there is a potential for interaction. This study investigated the interaction between ESL and lamotrigine in healthy subjects.Methods [ndash] Open-label study in two parallel groups of 16 healthy volunteers each. After an 8-day treatment with ESL or lamotrigine, ESL (1200 mg once-daily) and lamotrigine (150 mg once-daily) were co-administered for 19 days. Geometric mean ratios (GMR) and 90% confidence intervals (90% CI) for maximum plasma concentration (Cmax) and area under the plasma concentration[ndash]time curve in the dosing interval (AUC0[ndash]24) were calculated for eslicarbazepine (ESL active metabolite) and lamotrigine.Results [ndash] The Cmax and AUC0[ndash]24 GMR (90% CI) were, respectively, 95% (87[ndash]102%) and 96% (91[ndash]102%) for eslicarbazepine, and 88% (82[ndash]94%) and 86% (81[ndash]92%) for lamotrigine. The 90% CI of the Cmax and AUC0[ndash]24 GMR fell within the prespecified acceptance interval (80[ndash]125%) both for eslicarbazepine and lamotrigine. Conclusion [ndash] There was no significant pharmacokinetic interaction between ESL and lamotrigine in healthy subjects. Therefore, no dosage adjustment appears to be usually required in either lamotrigine or ESL when the drugs are co-administered.
