Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.
This study has been completed.
First Posted: October 20, 2010
Last Update Posted: January 31, 2012
Information provided by (Responsible Party):
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 Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
|Official Title:||Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Yonsei University:
Primary Outcome Measures:
- pb drug concentration [ Time Frame: 48 hours after administering phenobarbital ]pb drug concentration, CYP2C9/CYP2C19 polymorphism
|Study Start Date:||May 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
phenobarbital 20mg/kg iv infusion, after 24hours of loading, 2.5mg/kg bid daily
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