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- Title
Pharmacokinetics of Licarbazepine in Healthy Volunteers: Single and Multiple Oral Doses and Effect of Food.
- Authors
Souppart, Claire; Gardin, Anne; Greig, Gerard; Balez, Sebastien; Batard, Yannick; Krebs-Brown, Axel; Appel-Dingemanse, Silke
- Abstract
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, Cmaxss, and AUCτ 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.
- Subjects
DRUG tablets; DRUG administration; ORAL drug administration; DRUG dosage; PHARMACOKINETICS
- Publication
Journal of Clinical Pharmacology, 2008, Vol 48, Issue 5, p563
- ISSN
0091-2700
- Publication type
Article
- DOI
10.1177/0091270007313323