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...
Date First Received: November 28, 2005
Last Updated: November 28, 2005
Verified by: Odense University Hospital, March 2005
Clinical Trial Phase: Phase 4 | Start Date: April 2005
Overall Status: Active, not recruiting
Estimated Enrollment: 10
Brief Summary
Official Title: “Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Intervention(s) in this Clinical Trial
- Drug: carbamazepine oxcarbazepine
Outcome Measures for this Clinical Trial
Primary Measures
- Formation clearance of 3-hydroxyquinidine
Secondary Measures
- Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- BMI < 30
- Non smoker
- No signs or symptoms of disease by routine laboratory analysis, ECG and physical examination (general appearance assessment; pulmonal and cardiac stetoscopy; abdominal palpation)
- Informed consent
Exclusion Criteria:
- signs or symptoms of disease by routine laboratory analysis, ECG and physical examination
- mental disease
- participation in another clinical trial involving drugs with 3 months of randomization
- donation of more than 500 mL blood within 3 months of randomization
- intake of more than 21 alcohol equivanlents (one normal strength beer contain one alcohol equivalent)per week
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 40 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Odense University Hospital
Overall Clinical Trial Officials and Contacts
Per Damkier, MD, Ph.D. Principal Investigator Odense University Hospital
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00260247
Study ID Number: AKF-315
ClinicalTrials.gov Identifier: NCT00260247
Health Authority: Denmark: Danish Medicines Agency
Clinical Trials Authorship and Review
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