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

Tracking Information

First Received Date ^ICMJE

November 28, 2005

Last Updated Date

November 28, 2005

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Formation clearance of 3-hydroxyquinidine

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Condition ^ICMJE

Metabolic Clearance Rate

Intervention ^ICMJE

Drug: carbamazepine oxcarbazepine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

October 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00260247

Responsible Party

Study ID Numbers ^ICMJE

AKF-315

Study Sponsor ^ICMJE

Odense University Hospital

Collaborators ^ICMJE

The Danish Research Agency
Novartis

Investigators ^ICMJE

Principal Investigator:

Per Damkier, MD, Ph.D.

Odense University Hospital

Information Provided By

Odense University Hospital

Verification Date

March 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP