Evaluation of CYP2C9 Activity

Hadassah Medical Center

Status: Unknown

Conditions: Healthy

Treatments: Drug: Phenytoin single dose (300 mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT00162461

yc19559-HMO-CTIL

Details and patient eligibility

About

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

Enrollment: 1,200 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,200 participants in 1 patient group

Phenytoin

Experimental group

Treatment:

Drug: Phenytoin single dose (300 mg)