Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics

Exclusion Criteria

• •1. The average daily smoking are more than 5 cigarettes within 3 months prior to screening.
• •2. Known hypersensitivity and/or allergy to some drugs and food.
• •3. Known history of drug or alcohol abuse.(defined as consumption of 14 units of alcohol per week:1 unit=285ml of beer; or the equivalent of 25ml of spirit, or 100ml of wine )
• •4. Subjects who donated blood or bleeding profusely(\> 400 mL)in the 3 months preceding study screening.
• •5. Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs.
• •6. History or presence of any disease or condition known to increase the risk of bleeding, eg.acute gastritis, duodenal ulcer, etc.
• •7. Frequently suffers from postural hypotension.
• •8. History of frequent nausea or vomit causes by any etiology.
• •9. Concomitant therapy with any drugs with known hepatic enzyme-inducing or inhibiting agents that may change the activity of CYP3A4 prior to screening or during the study.
• •10. Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements within 14 days prior to screening.
• •11. History of having any special food(including dragon fruit,mango,grapefruit,etc.),strenuous exercises,or other factors may interfere with the absorption, distribution, metabolism, or excretion of drug within 14 days prior to screening.
• •12. Subjects with recent significant change in diet or exercise .
• •13. Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
• •14. Inability to consume the food provided in the study ( a high fat, high calorie meal includes two eggs for 100g, bacon 20g, a butter toast for 50g, french fries for 115g, whole milk for 240ml).This requirement only applies to subjects under fed condition.
• •15. Presence of clinically significant abnormalities in ECG or QTc\>470ms in males,or QTc\>480ms in females.
• •16. Pregnancy or breastfeeding at screening and during the study.All female subjects of childbearing potential must have a negative urine pregnancy test at screening and during the trial.
• •17. Any clinically significant abnormality upon physical examination or in the clinical laboratory tests. History or presence of a clinically significant gastrointestinal, renal, hepatic, neurologic, hematic, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular disorder(s) (but not limited to above disorders).
• •18. Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ),treponema pallidum antibodies at screening.
• •19. Any acute illness or concomitant medication from screening to first dosing.
• •20. Have chocolate, any food or beverage that contains caffeine or xanthine within 24 hours prior to dosing.
• •21. Take any product contains alcohol within 24 hours prior to dosing.
• •22. Positive for urine drug screening or history of substance abuse for a period of 5 consecutive years before screening.