Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00260247|
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : April 22, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Clearance Rate||Drug: carbamazepine oxcarbazepine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||October 2006|
- Formation clearance of 3-hydroxyquinidine
- Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260247
|University of Southern Denmark|
|Odense, Denmark, 5210|
|Principal Investigator:||Per Damkier, MD, Ph.D.||Odense University Hospital|