Acute Ischemic Stroke (AIS)
Conditions
Interventions
I-S group:phase I: Edaravone, i.v.gtt
phase II: Edaravone, sublingual administration
S-I ?:phase I: Edaravone, sublingual administration
phase I: Edaravone, i.v.gtt.
Multiple administration group:Edaravone, sublingual administration
Edaravone, i.v.gtt.
Sponsors
Liuzhou Workers' Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Healthy male and female adult, aged between 18 and 45 years, including both ends; 2) The body mass index (BMI) ranged from 19 to 26 kg/m2, including both ends; 3) There were no abnormal vital signs, physical examination, laboratory examination and ECG examination; 4) Subjects who were able to understand and sign informed consent prior to any trial related procedures.
Exclusion criteria
Exclusion criteria: 1) Those who are allergic to this product or any of its excipients (mannitol, hydroxypropyl methylcellulose, crosslinked polyvidone, silicon dioxide, magnesium stearate), allergic constitution or allergic to drugs and food; 2) Patients with a history of serious clinical diseases, severe liver function damage, or diseases of circulatory system, endocrine system, nervous system, hematology, immunology, psychiatry and metabolic abnormalities, and judged by the researcher to be unsuitable for the enrollment. Patients with history of epilepsy and convulsion; 3) Patients with history of repeated oral ulcer or oral ulcer, severe oral damage within 14 days before screening and no recovery, or those with abnormal oral mucosa confirmed by researchers; 4) ECG abnormalities (with clinical significance) or abnormal vital signs (systolic blood pressure = 140 mmHg, diastolic blood pressure = 90 mmHg; heart rate 100 BPM); 5) HBsAg, HCV antibody, HIV antibody or Treponema pallidum specific antibody were positive; 6) Alcoholics or regular drinkers within 6 months before screening, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml alcohol with 40% alcohol content or 150 ml wine); the results of alcohol breath test during screening period and on the day of admission were greater than 0.0 mg / 100 ml; 7) Those who smoked more than 3 cigarettes a day in the past three months or could not give up smoking during the whole trial period; or those who were positive for nicotine screening from screening period to the first administration; 8) Drug screening was positive; 9) Those who drank too much tea, coffee or caffeinated drinks within 3 months before screening (average more than 8 cups a day, 1 cup = 250 ml); or 48 hours before the first administration, those who take tea or any food or drink containing caffeine (such as coffee, chocolate, etc.); those who consume a lot of drinks or food containing special food (such as pitaya, mango, grapefruit, etc.) within 14 days before screening (such as grapefruit, grapefruit juice, grapefruit jam, etc.); or those who have consumed any drink or food rich in grapefruit (grapefruit) within 48 hours before the first administration of the drug; 10) Any drugs that inhibit or induce liver metabolism of drugs (such as: inducers-barbiturates, carbamazepines, phenytoin, glucocorticoids, Omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, and anti-depressants) were used 3 months before screening or during the trial; 11) Those who have taken any prescription or over-the-counter drugs, traditional Chinese medicine and health care products within 14 days before screening, or have received vaccination within 14 days before screening; 12) Those who participated in any other drug clinical trials as subjects within 3 months before screening; 13) Blood donation or blood loss more than 200 ml 3 months before screening; 14) Fertile subjects (male and female) did not agree to use reliable contraceptive methods such as IUD, ovarian cap, oral contraceptives, injectable progesterone, subcutaneous hormone implants or barrier method or abstinence during the study period and within 1 month after administration. The blood pregnancy test of female subjects from the screening period to the first administration was positive. Pregnant or lactating women; 15) Those who are
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
China
Contacts
Public ContactYazhou Wang
Liuzhou Workers' Hospital
Outcome results
None listed