The pharmacokinetic, safety, and tolerability profiles of eslicarbazepine acetate are comparable between Korean and White subjects.

ABSTRACT: Eslicarbazepine acetate (ESL) is a prodrug antiseizure medication for the treatment of focal seizures. ESL shows a well-established pharmacokinetic (PK)-pharmacodynamic relationship and has similar extrinsic epilepsy-related factors across ethnicities. This study evaluated and compared ESL safety, tolerability, and PK characteristics between Korean and White subjects. A randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study was conducted in healthy Korean and White adults. Participants randomly received a single dose and multiple oral doses of ESL (400-1600 mg) or placebo once daily for 11 days at a ratio of 8:2. Serial blood samples were collected to determine the plasma concentration of ESL and its metabolites (eslicarbazepine, [R-licarbazepine and oxcar

SUBMITTER: Hwang S 

PROVIDER: S-EPMC9468563 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature