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Completed

NCT Number: NCT00260247

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

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.

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Key information

Conditions

Metabolic Clearance Rate

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Southern Denmark

Odense, 5210, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbamazepine oxcarbazepine

Drug

Primary outcomes

  1. Formation clearance of 3-hydroxyquinidine

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Danish Research Agency
  • Novartis

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 1, 2005
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.