The Safety, Tolerability, and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Subjects

Exclusion Criteria

• •1.Subjects with serum creatinine, ALT and AST levels ≥1.5 times of the upper limit of normal value at screening.
• •2.Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
• •3\. Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
• •4\. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)# anaphylaxis physique.
• •5\. Use of any prescription or non-prescription medications within 14 days prior to initial dosing#Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
• •6\. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
• •7\. Positive results from urine drug screen test.
• •8\. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of \> 21 units/week), or positive results from alcohol breath test.
• •9.Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug, or inability to refrain from smoking during the course of the study.
• •10\. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
• •11\. Subjects who plan to receive or have had organ transplants.
• •12\. Subjects who participated in another clinical trial within 3 months prior to initial dosing.
• •13\. Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.