- Healthy, male or female, 21 to 55 years of age, body weight no less than 55 kg, Body
mass index (BMI) of 17.5 to 30.5 kg/m2. 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)
or clinical laboratory tests.
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, and other study procedures.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing), positive Hepatitis B surface antigen or
Human Immunodeficiency Virus (HIV) serology results.
- pregnant or nursing female,
- alcohol, drug, smoke user,
- sensitive to any study medication or related component,
- History or active gout,
- History or active tuberculosis,
- Known optic neuritis or other ophthalmological conditions.