Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions

A Phase I, Open-label, Single-center, Crossover Design of Food-effect Study of SH-1028 Tablets in Healthy Subjects

To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.

By analyzing safety and pharmacokinetics of SH-1028 Tablets in healthy subjects, pharmacokinetic characteristic will be evaluated mainly under fasting and fed conditions.Safety including AE/SAE is also a significant secondary objective.

Inclusion Criteria:

1. Healthy Subject with acceptable laboratory results.
2. BMI between 19 and 26; Weight between 50 and 80 kg
3. Not allowed to smoke or drink during the trial.
4. Subject should be willing to contracept during the study and until 6 months after completion of study.

Exclusion Criteria:

1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
2. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity
3. Addicted to smoking and drinking.
4. Hemorrhage over 200mL in 3 months before the trial.
5. Other conditions not suitable for trial, by judgement of investigator.