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

NCT ID: NCT00260247

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2006-10-31

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.

Conditions

Metabolic Clearance Rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

carbamazepine oxcarbazepine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Danish Research Agency

OTHER

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Per Damkier, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

University of Southern Denmark

Odense, , Denmark

Countries

Denmark

Other Identifiers

AKF-315

Identifier Type: -

Identifier Source: org_study_id