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Pharmacokinetics of Licarbazepine in Healthy Volunteers: Single and Multiple Oral Doses and Effect of Food
Author(s) -
Souppart Claire,
Gardin Anne,
Greig Gerard,
Balez Sebastien,
Batard Yannick,
KrebsBrown Axel,
AppelDingemanse Silke
Publication year - 2008
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270007313323
Subject(s) - pharmacokinetics , dosing , medicine , pharmacology , oral dose , geometric mean , oral administration , mathematics , statistics
Two studies characterized single‐ and multiple‐dose pharmacokinetics of licarbazepine immediate‐release tablets and food effects on single‐dose pharmacokinetics. In 1 study, 12 volunteers received 500 mg licarbazepine on day 1, 500 mg bid on days 3 to 6, and 500 mg on day 7. In the second study, 12 subjects received one 500‐mg licarbazepine dose under fasted and fed conditions. After multiple dosing, geometric mean (%CV) C max ss , C min ss , and AUC τ were 77.6 μmol/L (18), 45.3 μmol/L (25), and 747 hṁμmol/L (19), respectively, with a t max of 2 hours. Mean half‐lives were 9.3 and 11.3 hours for single and multiple dosing, respectively. Food had no clinically significant effect on single‐dose pharmacokinetics. Half‐life (∼10 hours) and low intersubject variability in main pharmacokinetic parameters were similar under fasted and fed conditions. Median t max increased from 1.5 to 2.5 hours with food. Licarbazepine is well tolerated and has predictable pharmacokinetics.