The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects

Inclusion criteria

• Subjects who are willing and are able to provide a written informed consent to participate in the study.
• Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.
• Subjects aged between 18 and 45 (both inclusive) years old.
• 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.
• 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

• 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.
• 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 stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
• Subjects with history of sleep-related illness.
• Subjects with history of severe involuntary hypoglycemia
• Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
• Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
• Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
• Positive results from urine drug screen test.
• 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.
• Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
• Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
• Subjects who plan to receive or have had organ transplants.
• Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
• Subjects who participated in another clinical trial within 3 months prior to initial dosing.
• Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.