- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
(Healthy is defined as no clinically relevant abnormalities identified by a detailed
medical history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead Electrocardiogram (ECG) and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
- An informed consent document signed and dated by the subject or a legally acceptable
- Evidence of history of clinically significant blood, kidney, endocrine,
gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug
allergies, but excluding untreated, asymptomatic, seasonal allergies at time of
dosing) disease or clinical findings at Screening.
- Active smokers or users of other tobacco products as well as users of certain drugs.
- Pregnant or nursing females; females of childbearing potential, including those with
tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who
are postmenopausal (defined as being amenorrheic for at least 2 years) must have
confirmatory Follicle-stimulating hormone (FSH) test results at Screening.