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

Yonsei University0 个研究点目标入组 52 人开始时间: 2008年5月1日最近更新: 2012年1月31日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Yonsei University
入组人数: 52
主要终点: pb drug concentration

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
盲法: None

入排标准

年龄范围: — 至 1 Year（Child）
性别: All
接受健康志愿者: 否

入选标准

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

排除标准

•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

结局指标

主要结局

pb drug concentration

时间窗: 48 hours after administering phenobarbital

pb drug concentration, CYP2C9/CYP2C19 polymorphism

次要结局

未报告次要终点

研究者

发起方

Yonsei University

申办方类型

Other

责任方

Sponsor

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