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Therapeutic Areas: Healthy Volunteers
Disease Category: Healthy Patient Studies
Location: United States, CA

Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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

To Learn more
Gender

Female

Age

20 to 45 Years

Overall Status

Recruiting

Facility Type

N/A

Contact

California Clinical Trials Medical Group, Inc.
1509 Wilson Terrace 55 Wing, Main Floor
Glendale, CA 91206-4007

View Map

Research Center Information: California Clinical Trials Medical Group, Inc.

CW ID: 112856

Date Last Changed: July 25, 2013


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