Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.
Information source: Odense University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Clearance Rate
Intervention: carbamazepine oxcarbazepine (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Odense University Hospital Official(s) and/or principal investigator(s):
Per Damkier, MD, Ph.D., Principal Investigator, Affiliation: Odense University Hospital
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.
Clinical Details
Official title: Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Formation clearance of 3-hydroxyquinidine
Secondary outcome: Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
University of Southern Denmark, Odense 5210, Denmark
Additional Information
Starting date: April 2005
Ending date: October 2005
Last updated: November 28, 2005
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