Official Title: “The Use of Phenytoin Metabolic Ratio as a Putative Marker of CYP2C9 Activity in-Vivo”

The use of phenytoin metabolism to produce S-HPPH accounts for more than 85% of its metabolism. This metabolic pathway is mediated by the activity of CYP2C9.

The purpose of the present study is:

1. To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity

2. To correlate phenytoin metabolic ratio with CYP2C9 genotype

3. To study the frequency distribution of CYP2C9 activity in-vivo

Study Type: Interventional

Study Design: Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Intervention(s) in this Clinical Trial

• Drug: Phenytoin single dose (300 mg)

Primary Measures

• Correlation between phenytoin metabolic ratio and CYP2C9 genotype
• Frequency distribution of phenytoin metabolic ratio in the population

Inclusion Criteria:

• Age range of 20-50 years old
• Absence of significant disease states

Exclusion Criteria:

• The presence of significant disease states
• The use of drugs (including birth control pills)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Hadassah Medical Organization

Overall Clinical Trial Officials and Contacts

Yoseph Caraco, MD Principal Investigator Hadassah Medical Organization  

Overall Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00162461

Study ID Number: yc19559-HMO-CTIL

ClinicalTrials.gov Identifier: NCT00162461

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration