NCT00260247

Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.

Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Metabolic Clearance Rate

Interventions

Type	Name	Description
DRUG	carbamazepine oxcarbazepine

Timeline

• Start date: 2005-04-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2005-12-01
• Last updated: 2015-04-22

Locations

1 site across 1 country: Denmark