Metabolic Clearance Rate Clinical Trial
Official title:
Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.
| Verified date | March 2005 |
| Source | Odense University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Medicines Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | October 2006 |
| Est. primary completion date | October 2006 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | University of Southern Denmark | Odense |
| Lead Sponsor | Collaborator |
|---|---|
| Odense University Hospital | Danish Research Agency, Novartis |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Formation clearance of 3-hydroxyquinidine | |||
| Secondary | Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine. |