Mild to moderate ischemic stroke
Conditions
Interventions
Pre-test group:All subjects are to be administrated single-dosed Brozopentyl Sodium by 12.5mg
50 mg group:Eight subjects are given Brozopentyl Sodium by 50 mg and two are given saline with single-dose.
25 mg group:Eight subjects are given Brozopentyl Sodium by 25 mg and two are given saline with single-dose.
100 mg group:Eight subjects are given Brozopentyl Sodium by 100 mg and two are given saline with single-dose.
200 mg group:Eight subjects are given Brozopentyl Sodium by 200 mg and two are given saline with single-dose.
300 mg group: Eight subjects are given Brozopentyl Sodium by 300 mg and two are given saline with single-dose.
400 mg group:Eight subjects are given Brozopentyl Sodium by 400 mg and two are given saline with single-dose.
Sponsors
Peking University First Hospital Phase 1 Clinical Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject attends the trial must meet all requirements below: 1. male or female age between 18 and 60,and the same sex ratio should not be less than one third; 2. body weight not less than 50 kg, and body mass index in the range of 19 to 25 kg/m2; 3. the test has been fully understood before the test, and volunteers to sign written informed consent; 4. be able to communicate with the researcher well and agree to complete the trial in accordance with trial protocol.
Exclusion criteria
Exclusion criteria: Volunteer satisfying any ctiteria below will be excluded: 1. Any Lab examination result abnormal and of clinical significance in screening period. 2. Female breastfeeding or pregnancy test positive. 3. Hepatitis B surface antigen, hepatitis C virus antibody, HIV antibody or treponema pallidum antibody test positive. 4. Systolic blood pressure> 140 mm Hg or 90 mm Hg. 5. Electrocardiogram results meet any of the following abnormalities: (1) male QTc>450 ms; female QTc>470 ms; (2) heart rate 100 times per min; (3) PR interval > 200 ms or 8 cups daily, 350 mL / cup) and can not stop drinking during the trial. 14. Volunteer with allergies, including those known to be allergic to test drugs or its excipients. 15. The volunteer or his/her spouse is unwilling or unable to take effective contraception or to suspend sexual activity during the trial. 16. Volunteer who has planned to have children in 6 months after the trial. 17. Volunteer who has taken medication that may affect evalution of the investigational drug in four weeks prior to screening, such as drugs that inhibit or induce liver metabolism of the investigational drug. 18. Volunteer who has taken any drug in one week prior to screening. 19. Volunteer with poor peripheral venous conditions. 20. Researchers think that should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tolerance evalution;Pharmacokinetics paramater; | — |
Countries
China
Contacts
Public ContactYimin Cui
Phase 1 Clinical Trial Center, Peking University First Hospital
Outcome results
None listed