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| Name | Class |
|---|---|
| Danish Research Agency | OTHER |
| Novartis | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbamazepine oxcarbazepine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Formation clearance of 3-hydroxyquinidine |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Damkier, MD, Ph.D. | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern Denmark | Odense | 5210 | Denmark |
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