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

Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metabolic Clearance Rate

Intervention: carbamazepine oxcarbazepine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Odense University Hospital

Official(s) and/or principal investigator(s):
Per Damkier, MD, Ph.D., Principal Investigator, Affiliation: Odense University Hospital

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.

Clinical Details

Official title: Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Formation clearance of 3-hydroxyquinidine

Secondary outcome: Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Male.

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

Locations and Contacts

University of Southern Denmark, Odense 5210, Denmark
Additional Information

Starting date: April 2005
Last updated: April 21, 2015

Page last updated: August 23, 2015

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