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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01224457

Enrollment

Registered

2010-10-20

Start date

2008-05-31

Completion date

2010-05-31

Last updated

2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Seizure

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.

Interventions

DRUGPhenobarbital

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
pb drug concentration	48 hours after administering phenobarbital	pb drug concentration, CYP2C9/CYP2C19 polymorphism

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026