Status:

COMPLETED

Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Healthy Subjects

Eligibility:

All Genders

18-50 years

Phase:

PHASE1

Brief Summary

This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjec...

Eligibility Criteria

Inclusion

  • Men and women, aged 18 to 50 years. Women of non-childbearing potential may be included.
  • Body mass index in the range of 18 to 30 kg/meter squared and body weight equal to or greater than 50 kg.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead electrocardiogram (graphic trace of the pattern of your heart beat).
  • Non-smoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history. Must abstain from smoking during inpatient stay.
  • Have a high probability for compliance with and completion of the study.

Exclusion

    Key Trial Info

    Start Date :

    July 1 2006

    Trial Type :

    INTERVENTIONAL

    End Date :

    August 1 2006

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00369304

    Start Date

    July 1 2006

    End Date

    August 1 2006

    Last Update

    August 7 2009

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