Healthy person
Conditions
Interventions
multiple dosing:Different doses of GW201/ placebo were taken once daily for 7 days
food effects:Once a day, wash for 7 days after taking one dose, and take a second dose
single-dose:Different doses of GW201 tablets/placebo were taken in a single dose
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) The subject voluntarily participates and signs a written informed consent; (2) At the time of signing the informed consent, age =18 years old and =45 years old, male or female; (3) Male weight is not less than 50.0kg, female weight is not less than 45.0kg, body mass index (weight/height 2) in the range of 19.0~26.0kg/m2 (including the upper and lower limits); (4) Normal or abnormal physical examination results have no clinical significance; (5) Normal or abnormal vital signs have no clinical significance; (6) The results of laboratory tests (routine blood routine, urine routine, blood biochemistry, coagulation function) are normal or abnormal without clinical significance; (7) female pregnancy test results are negative; (8) Serological (hepatitis B surface antigen, hepatitis C antibody, syphilis serum specific antibody, HIV antibody) test results are normal; (9) Normal or abnormal 12-lead electrocardiogram results have no clinical significance; (10) Normal or abnormal chest X-ray results have no clinical significance; (11) Normal or abnormal results of abdominal B-ultrasonography have no clinical significance; (12) Urine drug screening (morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, THC) was negative.
Exclusion criteria
Exclusion criteria: (1) Allergic constitution or history of drug or food allergy; (2) A history of any medical condition that may affect the safety of the trial or the course of the drug in vivo; (3) any history of surgery or trauma that may affect the safety of the trial or the process of the drug in vivo; (4) is currently suffering from any unstable or recurrent disease, or disease that affects the processes in the body of the drug; (5) a history of drug abuse/dependence within the past 2 years; (6) Use of any prescription or non-prescription drugs (excluding topical drugs) within 14 days prior to administration; (7) Smoking more than 5 cigarettes per day in the 3 months before screening or habitual use of nicotine products or cannot stop using any tobacco products during the test; (8) Alcohol consumption (more than 14 units per week (1 unit of alcohol ˜360mL beer with 5% alcohol or 45mL spirits with 40% alcohol or 150mL wine with 12% alcohol) in the three months prior to screening), or alcohol consumption within the week prior to medication, or the test period cannot abstain from alcohol, or the baseline alcohol breath test results are positive; (9) Participated in any interventional clinical study and received experimental drug or device therapy within 90 days prior to screening; (10) There has been blood loss or blood donation of 400mL or more within 90 days before screening; (11) A history of fainting needles or fainting blood; (12) lactating or pregnant women; (13) sperm or egg donation plans, fertility plans, unwillingness or inability to take effective contraceptive measures within six months from screening to the last dose; Female subjects had not used effective contraception for at least 1 month before screening; (14) There are neurological, mental state abnormalities or language disorders; (15) Due to other circumstances, the researcher considers it inappropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE;Clinical laboratory examination;Vital signs;12-lead electrocardiogram;physical examination;peak concentration;time to peak;area under the curve; | — |
Secondary
| Measure | Time frame |
|---|---|
| elimination half life;clearance rate; | — |
Countries
China
Contacts
Public ContactShi Aixin
Beijing Hospital
Outcome results
None listed