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Pharmacokinetics of Licarbazepine in Healthy Volunteers: Single and Multiple Oral Doses and Effect of Food

From Novartis Pharma AG, Basel, Switzerland (Dr Souppart, Dr Gardin, Dr Batard, Dr Krebs-Brown, Dr Appel-Dingemanse); F. Hoffmann-LaRoche Ltd, Basel, Switzerland (Dr Greig); and Novartis Pharma SAS, Rueil-Malmaison, France (Dr Balez).

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 were 77.6 µmol/L (18), 45.3 µmol/L (25), and 747 h·mol/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.

Key Words: Licarbazepine • pharmacokinetics • single dose • multiple dose

Address for correspondence: Claire Souppart, Novartis Pharma AG, WSJ 210.4.25, Basel, CH-4002, Switzerland; e-mail: claire.souppart{at}novartis.com.

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