Metabolic Clearance Rate
Conditions
Keywords
CYP3A4, Induction, Oxcarbazepine, Carbamazepine, Quinidine, Human, In vivo
Brief 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.
Interventions
DRUGcarbamazepine oxcarbazepine
Sponsors
Danish Research Agency
Novartis
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Formation clearance of 3-hydroxyquinidine | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine. | — |
Countries
Denmark
Outcome results
None listed