title: Pharmacokinetics of licarbazepine in healthy volunteers: single and multiple oral doses and effect of food.
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) Cmax ss, Cmin ss, and AUCtau were 77.6 micromol/L (18), 45.3 micromol/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 ( approximately 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.
authors.affiliation: Novartis Pharma AG, WSJ 210.4.25, Basel, CH-4002, Switzerland. claire.souppart@novartis.com
authors.forename: Claire
authors.initials: C
authors.lastname: Souppart
authors.forename: Anne
authors.initials: A
authors.lastname: Gardin
authors.forename: Gerard
authors.initials: G
authors.lastname: Greig
authors.forename: Sebastien
authors.initials: S
authors.lastname: Balez
authors.forename: Yannick
authors.initials: Y
authors.lastname: Batard
authors.forename: Axel
authors.initials: A
authors.lastname: Krebs-Brown
authors.forename: Silke
authors.initials: S
authors.lastname: Appel-Dingemanse
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D018592:Cross-Over Studies; D003984:Dibenzazepines / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D004305:Dose-Response Relationship, Drug; D005215:Fasting; D005260:Female; D005502:Food; D018565:Food-Drug Interactions; D006207:Half-Life; D006801:Humans; D008297:Male
chemical_list: D003984:Dibenzazepines; C428744:10,11-dihydro-10-hydroxy-5H-dibenz(b,f)azepine-5-carboxamide