Document Detail

The influence of food on the disposition of the antiepileptic oxcarbazepine and its major metabolites in healthy volunteers.
MedLine Citation:
PMID:  7993989     Owner:  NLM     Status:  MEDLINE    
The effect of food on the pharmacokinetics of the antiepileptic oxcarbazepine (OXC) was investigated in healthy volunteers. Six healthy male volunteers were treated with single peroral doses of 600 mg of oxcarbazepine (Trileptal) after overnight fasting or a fat- and protein-rich breakfast. Mean (+/- SD) areas under the plasma concentration-time curves (AUC) of the major component in plasma, the active monohydroxy metabolite (MHD), which is responsible for the therapeutic effect in man, were 672 (25) mumol L-1 h when given to the fasted volunteers and 780 (31) mumol L-1 h (p = 0.042) when given after a substantial breakfast. Mean (+/- SD) maximum concentrations (Cmax) were 25.5 (4.8) mumol L-1 when given to the fasted volunteers and 31.4 (5.3) mumol L-1 (p = 0.025) when given after breakfast. Thus, the average AUC was increased by 16% and Cmax by 23% when oxcarbazepine was given with food. The times at which Cmax was reached (tmax) as well as the terminal half-lives were not influenced by concomitant intake of food. The tolerability was the same whether oxcarbazepine was given before or after food in healthy volunteers. The slight effect of food on the kinetics of oxcarbazepine should be of little therapeutic consequence.
P H Degen; G Flesch; J M Cardot; C Czendlik; W Dieterle
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Biopharmaceutics & drug disposition     Volume:  15     ISSN:  0142-2782     ISO Abbreviation:  Biopharm Drug Dispos     Publication Date:  1994 Aug 
Date Detail:
Created Date:  1995-01-17     Completed Date:  1995-01-17     Revised Date:  2013-08-21    
Medline Journal Info:
Nlm Unique ID:  7911226     Medline TA:  Biopharm Drug Dispos     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  519-26     Citation Subset:  IM    
Ciba-Geigy Limited, Pharmaceuticals Division, Basel, Switzerland.
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MeSH Terms
Administration, Oral
Analysis of Variance
Anticonvulsants / administration & dosage,  blood,  pharmacokinetics*
Carbamazepine / administration & dosage,  analogs & derivatives*,  blood,  pharmacokinetics
Cross-Over Studies
Eating / physiology*
Fasting / metabolism
Middle Aged
Reg. No./Substance:
0/Anticonvulsants; 298-46-4/Carbamazepine; VZI5B1W380/oxcarbazepine

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