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

NCT00260247 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-04-22

No results posted yet for this study

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

DRUG

carbamazepine oxcarbazepine

Sponsors & Collaborators

  • Danish Research Agency

    collaborator OTHER

  • Novartis

    collaborator INDUSTRY

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Per Damkier, MD, Ph.D. · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00260247 on ClinicalTrials.gov