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

Phase 4

Completed

• Conditions: Metabolic Clearance Rate

• Registration Number: NCT00260247
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-03
• Study Start: 2005-04
• Study First Submitted: 2005-11-28
• Study First Submitted QC: 2005-11-28
• Study First Posted: 2005-12-01
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Formation clearance of 3-hydroxyquinidine

Secondary Outcome Measures

Name	Time	Method
Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.

Trial Locations

Locations (1)

University of Southern Denmark; 🇩🇰 Odense, Denmark