cerebral infarction
Conditions
Interventions
A:Phase 1, Group A1: 250 mg of Cinepazide mesylate injection Goup A2: 320 mg of Cinepazide maleate injection, once a day for 7 days. Phase 2, wash-out for 7 days. Phase 3: Group A1: 320 mg of Cinepazi
B:Three dimensional cross latin square design, the doses are 62.5, 125 and 250 mg per day.
Sponsors
National drug clinical trial agency of the 3rd hospital affiliated to Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18-45 yrs and the age difference should be less than 10 in one group; 2. Weight>50kg and BMI between 19 to 24 kg/m2; 3. Voluntarily signed the informed consent and having good adherence; 4. Urine pregnancy test is negative.
Exclusion criteria
Exclusion criteria: 1. Subjects experienced disease or surgery within last 4 weeks before recruitment; 2. Allergy to the trial drug; 3. Subjects having history of any severe disease or cardiovascular, endocrine, neurological, pulmonary, hematological, immune, psychological or metabolic disease; 4. Subjects had digestive, liver or kidney disease that could affect the drug absorption or metabolism; 5. Screen test (Count of blood cell, urine analysis and blood biochemical test) show clinically significant abnormality; 6. Abnormal ECG or vital sign (Systolic pressure 140 mmHg; diastolic pressure 90 mmHg; Heart rate 100 bpm) before or during the trial; 7. HIV test is positive; 8. HBsAb or hepatitis C test is positive; 9. Drug or alcohol abuse within 1 year before trial or during the trial; 10. Drinking alcohol more than 14 units within 6 months before trial or during the trial; 11. Used soft drugs (e.g. Marijuana) within 3 months before trial or during the trial; Used hard drugs (e.g. Cocaine, phencyclidine) within 12 months before trial or during the trial; 12. Used any medicine that can induce or inhibit the drug metabolism in liver (Inducers: e.g. barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: e.g. SSRIs, cimetidine, diltiazem macrolides, nitroimidazoles, verapamil, fluoroquinolones, anti-histamine) within 30 days before or during the trial; 13. Took any medicine within 14 days before the trial; 14. Participated any clinical trial within 3 months before the trial; 15. Donated blood 3 months before the trial or been selected as donator; 16. Subjects with coagulation disorder or thromboembolic disease; 17. Smoked more than 1 cigarette per day within 3 months before the trial, or taking any tobacco products during the trial; 18. Allergic to any food or not able to follow the diet instruction; 19. History of malignant tumor; 20. Significant Gallbladder disease; 21. Confirmed or suspicious jaundice, hepatic adenoma or adenocarcinoma or other liver disease; 22. Any visual impairment caused by ocular vascular disease; 23. Serious migraine or headache; 24. Consuming excessive tea, coffee or caffeine-containing drinks (> 8 cups); 25. Subjects that cannot finish the trial due to other reasons; 26. The researchers consider the subjects not suitable for this trial; Additional exclusion criteria for female subjects: 1. Taking contraceptive drugs orally within 30 days or during the trial; 2. Used long-acting estrogen or progesterone injection or embed tablets within 6 months or during the trial; 3. Women in childbearing age had non-protective intercourse within 14 days months or during the trial; 4. Breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs, ECG, Count of blood cell, urine analysis, liver and kidney function, blood suger and li; | — |
Countries
China
Contacts
Public ContactCaixia Huo
Outcome results
None listed