- Healthy male and/or female subjects.
- Subjects must be in reasonably good health as determined by the investigator based on
medical history, full physical examination (including blood pressure and pulse rate
measurement), 12 lead ECG and clinical laboratory tests.
- Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin
dependent diabetes, osteoarthritis may be enrolled if deemed medically prudent by the
- Subjects taking daily prescription or non-prescription medications for management of
acceptable chronic medical conditions must be on a stable dose.
- Body Mass Index (BMI) between 18 to 30 kg/m2, inclusive; and a total body weight >50
kg (110 lbs).
- Creatinine clearance greater than 30 mL/min using the Cockcroft-Gault method.
- Subjects with evidence or history of clinically significant hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurologic, immunologic, or allergic disease.
- Use of tobacco or any form of nicotine in the past 6 months.
- Greater than 7 drinks of alcohol per week for women, and greater than 14 drinks of
alcohol per week for men.