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

Yonsei University52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Neonatal Seizure

Interventions

PhenobarbitalDRUG

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

Eligibility

Sex: ALLMax age: 1 Year

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

pb drug concentration

pb drug concentration, CYP2C9/CYP2C19 polymorphism

Time frame: 48 hours after administering phenobarbital

Data from ClinicalTrials.gov

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