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

• Status: Completed
• Trial end date: 2019-12-06
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Criteria

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.