Subjects
Healthy volunteers that meet the inclusion criteria and not the
exclusion criteria were enrolled in the study after the clinical and
laboratory examinations. The inclusion criteria included as
follows:1)healthy male and female aged over 18years;2)the Body Mass
Index is in the range of19.0 to 26.0 kg/m2 (both
inclusive), and males with minimum of 50 kg weight, females with minimum
of 45kg weight; 3)subjects have no clinically significant abnormalities,
including vital signs, physical examinations, laboratory tests, and ECG
as determined by clinical examination; 4)agree to follow approved birth
control methods.
Subjects were excluded if any of the following conditions were present:
1)allergic diathesis or hypersensitivity toinvestigational products;
2)history or presence of significant cardiovascular, urogenital,
pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological,
dermatological, neurological or psychiatric disease or disorder, or
other medical history affecting drug absorption; 3)use of any drugs or
herbal medicinewithin 14 days; 4)smoking more than five cigarettes a
day, abuse of alcohol or drugs, drinking too much tea, coffee or
caffeinated drinks (more than 8 cups a day, 250ml/cup); 5)donation or
loss of blood or plasma >400mL in the past 3 months;
6)consumption of any beverages or food containing caffeine or products
rich in grapefruit, such as coffee, tea and chocolate, etc,within 48
hours prior toreceiving study drug.