Pharmacokinetics of lacosamide in healthy korean male volunteers.

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