Medical History
1. Presence or history of any disorder that may prevent the successful completion of the
study.
2. Any unstable medical condition.
3. History of seizures.
4. History of cardiac disorders (other than hypertension) including but not limited to
valvular disease, congestive heart failure, angina pectoris, myocardial infarction, or
arrhythmia.
5. Any significant cardiovascular disease, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
6. Any surgical or medical condition that may interfere with the absorption,
distribution, metabolism, or excretion of the test article (eg, resection of liver,
kidney, gallbladder, or gastrointestinal tract).
7. Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7
days before study day 1).
8. History of drug abuse within 1 year before study day 1.
9. Admitted alcohol abuse or history of alcohol use that may interfere with the subject's
ability to comply with the protocol requirements.
Physical and Laboratory Findings
10. Clinically significant electrocardiogram (ECG) abnormalities.
11. Any clinically important deviation from normal limits in physical examination
findings, vital sign measurements, 12-lead ECGs, or clinical laboratory test results.
12. Positive serologic findings for human immunodeficiency virus (HIV) antigen and
antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV)
antibodies.
13. Positive findings of urine drug screen (eg, amphetamines, barbiturates,
benzodiazepines, cannabinoids, cocaine, opiates, and phencyclidine [PCP]).
14. Troponin T or CK-MB levels above reference range at screening. Allergies and Adverse
Drug Reactions
15. History of any clinically important drug allergy (eg, relapsing dermatitis, drug
hypersensitivity, drug allergy, hypersensitivity to ingredient in the test articles,
angioedema).
Prohibited Treatments
16. Use of any investigational drug within 90 days before study day 1 or prescription drug
within 30 days before study day 1.
17. Tobacco use or the consumption of any caffeine-containing products (eg, coffee, tea,
chocolate, or carbonated beverages) or alcoholic beverages within 72 hours before
study day 1 until the end of the inpatient confinement period.
18. Consumption of grapefruit or grapefruit-containing products within 72 hours before
study day 1 until the end of the inpatient confinement period.
19. Use of any over-the-counter drugs, including herbal supplements (except for the
occasional use of vitamins ?100% of the recommended daily allowance), within 14 days
before study day 1 (St. John wort is prohibited within 30 days of study day 1).
20. Donation of blood within 90 days before study day 1. Others
21. Subjects deemed by the investigator to be inappropriate according to the inclusion
criteria in the study and according to the screening examination.