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OpenTrials
Completed

NCT Number: NCT01224457

Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.

The pharmacogenomic profiles of drug metabolizing enzymes play an important role in pharmacokinetics (PK) of drugs. Phenobarbital (PB), worldwidely used for neonatal seizure, is a drug that requires careful dose adjustments based on therapeutic drug monitoring. It was reported that phenobarbital (PB) metabolism was affected by CYP2C9 and CYP2C19 polymorphisms in adults. This study aims to evaluate the effects of the CYP2C9 and CYP2C19 genetic polymorphisms on PB PK in infants with neonatal seizure for an optimal dosing strategy.

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Key information

Conditions

Neonatal Seizure

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infant treated by phenobarbital monotherapy, diagnosed neonatal seizure
  • Infant taken the drug concentration one more time
  • given the informed consent

Exclusion criteria

  • progressed CNS disorder
  • severe systemic illness
  • GOT/GPT level more than 2times of normal value,more than 3times elevation of BUN/creatinine level
  • congenital hemolytic anemia
  • genetic disorder

Treatment and study plan

Phenobarbital

Drug

phenobarbital 20mg/kg iv infusion, after 24hours of loading, 2.5mg/kg bid daily

Primary outcomes

  1. pb drug concentration

    Time frame: 48 hours after administering phenobarbital

    pb drug concentration, CYP2C9/CYP2C19 polymorphism

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 20, 2010
Registry last updated
Jan 31, 2012

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.

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