Acute Ischemic Stroke
Conditions
Interventions
1:4 subjects dose with TBN 50 mg and 2 sunjects dose with placebo
2:4 subjects dose with TBN 100 mg and 2 sunjects dose with placebo
3:6 subjects dose with TBN 200 mg and 2 sunjects dose with placebo
4:8 subjects dose with TBN 400 mg and 2 sunjects dose with placebo
5:8 subjects dose with TBN 700 mg and 2 sunjects dose with placebo
6:8 subjects dose with TBN 1000 mg and 2 sunjects dose with placebo
7:8 subjects dose with TBN 1400 mg and 2 sunjects dose with placebo
8:6 subjects dose with TBN 1800 mg and 2 sunjects dose with placebo
Sponsors
First Hospital, Peking University, China
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Healthy male and female subjects, age between 18 to 65 years old; 2) Male weighing over 50Kg,Female weighing over 45kg, body weight index within 19.0-28.0kg/m2 (Includ the boundary value); 3) Vital signs, body examination, laboratory examination and other related trial examination at normal range or no clinical significant abnormal results before study; 4) No history of smoking addiction, no history of alcohol addiction and no hisstory of drug abuse; 5) Subjects should comply with protocol of trail; 6) Signed and dated a written Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Vital signs, body examination, ECG, laboratory examination at clinical significant abnormal results before study; 2. In a quiescent condition of subject, systolic pressure100 bpm; 3. History of drug allergy to tetramethylpyrazine, nitrone or ingredients in TBN injection; 4. Subjects could not comply with the dietary standard of trail, or history of food allergy; 5. History of any severe disease or abnormal in circulatory system, endocrine system, nervous system, hematology, immunology, pathergasiology, metabolic, and so on; 6. History of strenuous exercise within 2 weeks; 7. History of drug use within 2 weeks; 8. Have serology positive for antibodies to HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) and syphilis at screening; 9. History of alcohol addictive or alcohol drinking over 14 unite per week within 6 months (1 unite=360 ml beers/45 ml spirit (alcohol concentration over 40%) /150 m wine); 10. History of smoking addiction, or smoking over 5 cigarette amount within 3 month, or could not comply with smoking prohibited during the trial; 11. History of drug addiction (eg. Marihuana, cocaine, phencyclidine, and so on); 12. Have a disease with clinical significant abnormal or a history of surgical operation within 4 weeks 13. History of clinical trail within 3 months, or blood donation/hemorrhage =400 ml within 3 months; 14. Gestation or suckling period female; 15. Female and male subjects had not take action with contraceptives or had family planning within 6 months; 16. The other inappropriate factor which judged by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine examination;Blood biochemistry;Urine rutine;Blood coagulation and haemolysis;Vital signs;Body examination;ECG; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacoketics; | — |
Countries
China
Contacts
Public ContactYuan Lv
First Hospital, Peking University, China
Outcome results
None listed