title: Pharmacokinetics of lacosamide in healthy korean male volunteers.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmacology and Clinical Pharmacology, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
authors.forename: Sung Eun
authors.initials: SE
authors.lastname: Kim
authors.forename: Namyi
authors.initials: N
authors.lastname: Gu
authors.forename: Bo-Hyung
authors.initials: BH
authors.lastname: Kim
authors.forename: Andreas
authors.initials: A
authors.lastname: Fitchner
authors.forename: Jan-Peer
authors.initials: JP
authors.lastname: Elshoff
authors.forename: Willi
authors.initials: W
authors.lastname: Cawello
authors.forename: In-Jin
authors.initials: IJ
authors.lastname: Jang
authors.forename: Kyung-Sang
authors.initials: KS
authors.lastname: Yu
mesh_terms: D000081:Acetamides / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D044466:Asian People; D004311:Double-Blind Method; D006801:Humans; D000078334:Lacosamide; D008297:Male; D044465:White People; D055815:Young Adult
chemical_list: D000081:Acetamides; D000927:Anticonvulsants; D000078334:Lacosamide