Acute ischemic stroke
Conditions
Interventions
single dose incremental group-1:30 mg edaravone + 6 mg dextran
single dose incremental group-2:60 mg edaravone + 12 mg dextran
single dose incremental group-3:90 mg edaravone + 18 mg dextran
multiple dose incremental group-1:30 mg edaravone + 6 mg dextran, b.i.d., 9 times continuously
multiple dose incremental group-2:60 mg edaravone + 12 mg dextran, b.i.d., 9 timescontinuously
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult males and females, aged between 18 and 55 years, including both ends; 2. Male body weight (= 50 kg) and female body weight (= 45 kg). Body mass index (BMI) ranges from 18 kg/m2 to 30 kg/m2; 3. Women of childbearing age with negative in blood pregnancy tests during screening and hospitalization, and agreed to use approved alternative family planning methods during the study period; 4. Subjects who understand and sign informed consent prior to any trial-related procedures.
Exclusion criteria
Exclusion criteria: 1. Screening for patients with clinically significant diseases or surgical procedures within the first four weeks; 2. Those who are definitely allergic to this product or any of its excipients (mannitol, copolyvinyl ketone, microcrystalline cellulose, cross-linked polyvinyl ketone, silica, magnesium stearate); 3. Have any history of serious clinical diseases or diseases such as circulatory system, endocrine system, nervous system diseases or hematology, immunology, psychiatric diseases and metabolic abnormalities. Patients with epilepsy or convulsion history; 4. Those who had a history of recurrent oral ulcer or had oral ulcer, severe oral lesions and no recovery within 14 days before screening, or those whose oral mucosal abnormalities were confirmed by the researchers'examination; 5. abnormal electrocardiogram (with clinical significance) or abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg, heart rate 100 bpm); 6. HIV positive, syphilis positive, hepatitis B surface antigen positive or hepatitis C positive; 7. Alcoholics or regular drinkers within 6 months before the trial, i.e. those who drank more than 14 units of alcohol per week (1 unit = 360 mL beer or 40% spirits or 150 mL wines with 45 mL alcohol); 8. Those who smoked more than three cigarettes a day on average in the past three months or who could not give up smoking during the whole trial period; 9. Positive drug screening; 10. Nicotine screening positive; 11. Anyone who is allergic to any food or has special dietary requirements and is unable to comply with a unified diet; 12. Drinking excessive tea, coffee and/or caffeinated beverages (more than 8 cups) daily or taking special diets (including pitaya fruit, mango, grapefruit, etc.) within two weeks before screening; 13. Any drugs that inhibit or induce liver metabolism (e.g. inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, town) were used in the first three months of screening or during the experiment. Those with hypnotics, verapamil, fluoroquinolones and antihistamines; 14. Take any prescription or over-the-counter drugs, traditional Chinese medicine or Chinese herbal medicine, health products within 14 days before screening, or have received vaccination within 14 days before screening; 15. Participating in any other drug clinical trial as a subject within three months before the trial; 16. Blood donation or blood loss exceeding 400 ml 3 months before the trial; 17. Fertile subjects (men and women) disagreed with the use of reliable contraceptive methods such as IUD, ovarian caps, oral contraceptives, injectable progesterone, subcutaneous hormone implants or barrier or abstinence during the study period and within 6 months after administration. Pregnant or lactating women; 18. Subjects may not be able to complete this study for other reasons or those whom the researchers believe should not be included; 19. abnormal vital signs, physical examinations, laboratory examinations and electrocardiograms with clinical significance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration; | — |
Countries
China
Contacts
Public ContactJinliang Yao
Yantai Yene Pharma Co, Ltd
Outcome results
None listed