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PHARMACOKINETICS

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

Claire Souppart, Chem Eng, Anne Gardin, PhD, Gerard Greig, MD, MSc, Sebastien Balez, PharmD, Yannick Batard, PhD, Axel Krebs-Brown, PhD and Silke Appel-Dingemanse, PhD

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) Cmaxss, Cminss, and AUC{tau} were 77.6 µmol/L (18), 45.3 µmol/L (25), and 747 h·mol/L (19), respectively, with a tmax 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 tmax 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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