Last updated on May 2007

An inpatient study looking at the safety, pharmcokinetics, and pharmacodynamics of an investigational drug administered to healthy Japanese and non-Japanese female subjects.


Brief description of study

An inpatient study looking at the safety, pharmcokinetics, and pharmacodynamics of an investigational drug administered to healthy Japanese and non-Japanese female subjects.

Detailed Study Description

Inclusion Criteria

  • Healthy Japanese or Non-Japanese Females
  • 20 to 45 years of age
  • Nonsmoker or smoker of less than 10 cigarettes a day
  • Nonpregnant, nonlactating, and not using hormonal contraception
  • Japanese subjects will be first-generation Japanese subjects, defined as being born in Japan but living outside of Japan for < 5 years
  • Non-Japanese subjects must be self identified as non-Japanese
  • Body weight = 50 kg
  • Japanese BMI 17.6 to 26.4 kg/m2
  • Non-Japanese BMI 18.0 to 30.0 4 kg/m2

Length of study - Approximately: 7 weeks

Inpatient: (length of hospital stay) 19 day (18 night)

Total number of outpatient visits: 1 telephone follow up contact

Clinical Study Identifier: TX134275

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California Clinical Trials Medical Group, ...

California Clinical Trials Medical Group, Inc.
Glendale, CA USA
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