Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.
Not Applicable
Completed
- Conditions
- Neonatal Seizure
- Registration Number
- NCT01224457
- Lead Sponsor
- Yonsei University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method pb drug concentration 48 hours after administering phenobarbital pb drug concentration, CYP2C9/CYP2C19 polymorphism
- Secondary Outcome Measures
Name Time Method