stroke
Conditions
Interventions
All dose groups:Idaravone injection/idaravone injection were administered under the tongue
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) healthy adult male and female subjects, ages 18-55 years, including both ends; 2) male body weight =50kg, female body weight =45kg, body mass index (BMI) between 18 ~ 30kg /m2 includes both ends. 3) women of childbearing age have negative blood pregnancy test during screening and hospitalization, have not breast-fed, have no intention of pregnancy during the study period, and agree to use the approved alternative family planning method during the study period. 4) no abnormal vital signs, physical examination, laboratory examination, electrocardiogram and other results of clinical significance. 5) subjects who can understand and sign informed consent prior to any test procedures.
Exclusion criteria
Exclusion criteria: 1) patients suffering from clinically significant diseases or undergoing surgery within 4 weeks before screening; 2) clear allergy to this product or any of its excipients (mannitol, hydroxypropyl cellulose, cross-linked polyvioxone, silica, magnesium stearate); 3) any history of serious clinical diseases or diseases of circulatory system, endocrine system, nervous system or hematology, immunology, psychiatry and metabolic disorders.Having a history of epilepsy or convulsion; 4) patients with a history of recurrent oral ulcer or who had oral ulcer or severe oral injury within 14 days prior to screening and did not recover, or who were examined and confirmed by researchers to have abnormal oral mucosa; 5) abnormal ecg (clinically significant) or abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg;Heart rate 100 BPM); 6) positive HIV test, positive syphilis test, positive hepatitis b surface antigen test or positive hepatitis c test; 7) heavy drinkers or regular drinkers in the 6 months prior to the trial, who drink more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); 8) the average number of cigarettes smoked per day over the past three months is more than 3 or smokers should not be given up during the whole trial period; 9) positive drug screening; 10) positive nicotine screening; 11) any food allergy or special requirements on diet, who cannot follow the uniform diet; 12) excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups) per day or special diet (including dragon fruit, mango, grapefruit, etc.) within 2 weeks prior to screening; 13) any drug that inhibits or induces drug metabolism in the liver (e.g., inducers -- barbiturates, carbamazepines, phenytoins, glucocorticoids, omeprazole) was used 3 months prior to screening or during the trial;Inhibitors -- SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 14) those who have taken any prescription or non-prescription medicine, traditional chinese medicine or chinese herbal medicine, or health care products within 14 days prior to screening, or who have received vaccination within 14 days prior to screening; 15) participate in any other drug clinical trial as a subject within 3 months prior to the trial; 16) blood donation or blood loss exceeding 400ml 3 months before the test; 17) fertile subjects (male and female) were not intended to use reliable contraceptive methods such as IUD, ovarian cap, oral contraceptive, injectable progesterone, subcutaneous hormone implant or barrier method or abstinence during the study period and for six months after administration.Women of reproductive age tested positive for blood pregnancy within 48 hours prior to enlistment.Pregnant or lactating women. 18) subjects may not be able to complete this study due to other reasons or should not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
China
Contacts
Public ContactFeng Shao
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed