Acute Ischemic Stroke
Conditions
Interventions
Group 1:700 mg dose of TBN for once of each subjects
Group 2:1400 mg dose of TBN for once of each subjects
Sponsors
First Hospital, Peking University, China
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Healthy male and female subjects, aged between 18 to 65 years old; 2) Male weighing over 50Kg,Female weighing over 45kg, body weight index within 19.(Includ the boundary value); 3) Vital signs, body examination, laboratory examination and other related trial examination at normal range or no clinical signific results before study; 4) Subjects should comply with protocol 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 first dose; 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) Infectious diseases screening shows any positive results of HBV, HCV, HIV, Treponema Pallidum; 9) 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) Smoking over 5 cigarette amount within 3 month, or could not comply with smoking prohibited during the trial; 11) History of drug addiction or positive for drug addiction screening within 6 months; 12) Have a disease might influence the absorb, distrubtion, metabolism and excretion of investigational product, or a history of surgical operation within 4 weeks; 13) History of clinical trail within 3 months; 14) Blood donation/hemorrhage =400 ml, recevied homologous transfusion and used blood product within 3 months; 15) Gestation or suckling period female; 16) Female and male subjects had not take action with contraceptives or had family planning within 6 months; 17) Subjects intolerance with intravenous administration; 18) 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;Pharmacoketics;Electrocardio;Vital signs;Body examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| 8-OHdG;IL-6;TNF-a; | — |
Countries
China
Contacts
Public ContactYuan Lv
First Hospital, Peking University, China
Outcome results
None listed