Pharmacokinetics of licarbazepine in healthy volunteers: single and multiple oral doses and effect of food
| Autor: | Axel Krebs-Brown, Anne Gardin, Yannick Batard, Claire Souppart, Silke Appel-Dingemanse, Gerard Greig, Sebastien Balez |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Adult
Male Cmax Administration Oral Biological Availability Pharmacology chemistry.chemical_compound Cmin Food-Drug Interactions Pharmacokinetics Dibenzazepines Medicine Humans Pharmacology (medical) Licarbazepine Cross-Over Studies Dose-Response Relationship Drug business.industry Half-life Fasting Crossover study Dose–response relationship chemistry Food Area Under Curve Female Geometric mean business Half-Life |
| Zdroj: | Journal of clinical pharmacology. 48(5) |
| ISSN: | 0091-2700 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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