drugset / Trial / NCT01224457

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

NCT01224457

Completed 52 enrolled Yonsei University
NaSingle-groupOpen-label

Summary

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.

Timeline

Start
2008-05
Primary completion
2010-04
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Phenobarbital Unknown 2.5 mg/kg Intravenous