Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.
This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree.
This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity.
It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.|
- Formation clearance of 3-hydroxyquinidine
- Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.
|Study Start Date:||April 2005|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260247
|University of Southern Denmark|
|Odense, Denmark, 5210|
|Principal Investigator:||Per Damkier, MD, Ph.D.||Odense University Hospital|