Trials / Completed
CompletedNCT01224457
Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Yonsei University · Academic / Other
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Phenobarbital | phenobarbital 20mg/kg iv infusion, after 24hours of loading, 2.5mg/kg bid daily |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2010-04-01
- Completion
- 2010-05-01
- First posted
- 2010-10-20
- Last updated
- 2012-01-31
Source: ClinicalTrials.gov record NCT01224457. Inclusion in this directory is not an endorsement.