Pharmacokinetics of Lacosamide in Healthy Korean Male Volunteers

• DOI: 10.1159/000336774
• Publication Date: 2012-03-13T09:54:50Z
• Authors: Sung Eun Kim; Namyi Gu; Bo-Hyung Kim; Andreas Fitchner; Jan-Peer Elshoff; Willi Cawello; In-Jin Jang; Kyung-Sang Yu
• Keywords: Lacosamide; Pharmacodynamics

<i>Aim: </i>The aim of this study was to evaluate the pharmacokinetics (PK) single and repeated doses lacosamide in healthy male Korean volunteers compare PK profile Caucasian populations. <i>Methods:</i> In a double-blind, placebo-controlled, parallel-group, dose-escalation trial, 16 received dose (50 mg) or placebo, 32 were administered single/repeated twice-daily (100 200 placebo. <i>Results:</i> For multiple 100 mg twice daily, geometric means C<sub>max,ss</sub> 6.23 (15.0) 13.13 (8.9) µg/ml respectively, AUC<sub>τ</sub><sub>,s</sub><sub>s</sub> values 52.10 (17.0) 112.35 (13.0) µg·h/ml, respectively. Values for both parameters relatively higher than those seen Caucasians. To further describe ethnic differences, population analysis assessed. A one-compartment model with first-order absorption elimination selected effects CL<sub>creatinine</sub> on CL/F body surface area V/F included final model. <i>Conclusion:</i> There no other differences between Koreans Caucasians based analysis, except demographic differences.