Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.

Odense University Hospital

Status and phase

Completed

Phase 4

Conditions

Metabolic Clearance Rate

Treatments

Drug: carbamazepine oxcarbazepine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00260247

AKF-315

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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