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Population pharmacokinetic analysis for 10-monohydroxy derivative of oxcarbazepine in Japanese pediatric epileptic patients

Sugiyama, Ikuo and Bouillon, Thomas and Yamaguchi, Masayuki and Suzuki, Hikoe and Hirota, Takashi and Fink, Martin (2015) Population pharmacokinetic analysis for 10-monohydroxy derivative of oxcarbazepine in Japanese pediatric epileptic patients. Drug Metabolism and Pharmacokinetics .

Abstract

Oxcarbazepine is an anti-epileptic drug, which is almost completely metabolized by cytosolic enzymes in the liver to the active 10-monohyroxy metabolite (MHD) following oral administration. The pharmacokinetic (PK) profiles of MHD were evaluated in Japanese pediatric epileptic patients and a possible ethnic difference in PK of MHD between Japanese and non-Japanese pediatric patients was assessed. A non-linear mixed effect modeling approach was used to determine the PK of MHD. A one-compartment population model with first-order absorption appropriately described the PK of MHD. No clinically relevant differences were found for using body surface area or weight to explain between-patient variability, therefore the final model included the effects of body weight on apparent clearance (CL/F) and apparent volume of distribution (V/F) of MHD, and in addition, the effect of 3 concomitant anti-epileptic drugs (carbamazepine, phenobarbital and phenytoin) on CL/F of MHD. Inclusion of ethnicity as a covariate in the final model, concluded no ethnic difference with respect to CL/F of MHD between Japanese and non-Japanese patients. Hence, oxcarbazepine can be generally applied using the same dosage and administration for the treatment of partial onset seizures in pediatric patients, regardless of ethnicity.

Item Type: Article
Keywords: Population PK, oxcarbazepine, Japanese population, pediatrics, epilepsy, ethnic sensitivity assessment
Date Deposited: 28 Apr 2016 23:45
Last Modified: 28 Apr 2016 23:45
URI: https://oak.novartis.com/id/eprint/23045

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