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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2005 by Odense University Hospital. Recruitment status was Active, not recruiting

First Received on November 28, 2005. No Changes Posted

Sponsor:	Odense University Hospital
Collaborators:	Danish Research Agency Novartis
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00260247

Purpose

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.

Condition	Intervention	Phase
Metabolic Clearance Rate	Drug: carbamazepine oxcarbazepine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.

Resource links provided by NLM:

Drug Information available for: Oxcarbazepine Carbamazepine

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:

Formation clearance of 3-hydroxyquinidine

Secondary Outcome Measures:

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

Estimated Enrollment:	10
Study Start Date:	April 2005
Estimated Study Completion Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260247

Locations

Denmark
University of Southern Denmark
Odense, Denmark, 5210

Sponsors and Collaborators

Odense University Hospital

Danish Research Agency

Novartis

Investigators

Principal Investigator:

Per Damkier, MD, Ph.D.

Odense University Hospital

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00260247 History of Changes
Other Study ID Numbers:	AKF-315
Study First Received:	November 28, 2005
Last Updated:	November 28, 2005
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:

CYP3A4
Induction
Oxcarbazepine
Carbamazepine

Quinidine
Human
In vivo

Additional relevant MeSH terms:

Carbamazepine
Oxcarbazepine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012