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Disease Category: Healthy Patient Studies

Trial Information

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

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

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

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