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Sponsors and Collaborators: |
Odense University Hospital The Danish Research Agency Novartis |
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Information provided by: | Odense University Hospital |
ClinicalTrials.gov Identifier: | NCT00260247 |
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 | Intervention | Phase |
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Metabolic Clearance Rate |
Drug: carbamazepine oxcarbazepine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4. |
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
University of Southern Denmark | |
Odense, Denmark, 5210 |
Principal Investigator: | Per Damkier, MD, Ph.D. | Odense University Hospital |
Study ID Numbers: | AKF-315 |
Study First Received: | November 28, 2005 |
Last Updated: | November 28, 2005 |
ClinicalTrials.gov Identifier: | NCT00260247 |
Health Authority: | Denmark: Danish Medicines Agency |
CYP3A4 Induction Oxcarbazepine Carbamazepine |
Quinidine Human In vivo |
Oxcarbazepine Carbamazepine Quinidine |
Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |