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Evaluation of CYP2C9 Activity

H

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)

1,200 participants in 1 patient group

Phenytoin
Experimental group
Treatment:
Drug: Phenytoin single dose (300 mg)

Trial contacts and locations

1

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Central trial contact

Yoseph Caraco, MD

Data sourced from clinicaltrials.gov

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