Last updated: May 6, 2021
Sponsor: Sunshine Lake Pharma Co., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Insomnia
Treatment
N/AClinical Study ID
NCT04667429
HEC83518-P-02 / CRC-C2048
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects who are willing and are able to provide a written informed consent toparticipate in the study.
- Without Plan for pregnancy or pregnant within 3 months after enrollment throughout thetrial.
- Subjects aged between 18 and 45 (both inclusive) years old.
- Healthy volunteers have a body weight ≥50 kg (for male) or ≥ 45kg (for female) andbody mass index ≥18 and ≤28 kg/m2 at screening.
- Subjects, who are healthy, as having no clinically significant abnormalities in vitalsigns, physical examination, clinical laboratory test results, Chest X-ray and 12-leadelectrocardiogram (ECG).
Exclusion
Exclusion Criteria:
- Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screeningor baseline.
- Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies,hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TPantibodies at screening.
- Subjects with history of digestive system,urinary system, liver,central nervoussystem, blood system, endocrine system,respiratory system,immune system,cardiovascularsystem,and/or malignant tumor or others medical conditions (such as history of mentalillness, etc.) that are not suitable for clinical trial participation;Subjects withhistory of stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, oracute 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 drugformulation(s) ,or anaphylaxis physique.
- Use of any prescription or non-prescription medications within 14 days prior toinitial dosing,or Use of any medications known to inhibit or induce cytochrome Penzyme drug metabolism within 28 days prior to initial dosing.
- Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruitwithin 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 asAlcohol consumption of > 21 units/week), or positive results from alcohol breath test.
- Regular smoking of more than 10 cigarettes per day within 3 months beforeadministration 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 forwomen of child-bearing potential. 15 Subjects who participated in another clinicaltrial within 3 months prior to initial dosing.
16.Any other condition with in the opinion of the investigator would render the patientunsuitable for inclusion in the study.
Study Design
Total Participants: 52
Study Start date:
January 18, 2021
Estimated Completion Date:
October 31, 2021
Connect with a study center
The Shanghai Xuhui Central Hospital
Shanghai, Shanghai
ChinaActive - Recruiting

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