The Safety, Tolerability, and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Subjects
The Safety, Tolerability, and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy Subjects
The Safety, Tolerability and Pharmacokinetics Study of HEC113995 PA•H2O Tablets in Healthy
 Male and Female Subjects
Inclusion Criteria:

 -  1. Subjects who are willing and are able to provide a written informed consent to
 participate in the study.

 -  2. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout
 the trial.

 -  3. Subjects aged between 18 and 45 (both inclusive) years old.

 -  4. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and
 body mass index ≥18 and ≤28 kg/m2 at screening.

 -  5. Subjects, who are healthy, as having no clinically significant abnormalities in
 vital signs, physical examination, clinical laboratory test results, Chest X-ray and
 12-lead electrocardiogram (ECG).

 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.