acute ischemic stroke
Conditions
Interventions
Pretest group:Hydroxysafflower yellow A for injection 75mg
Single-dose group:Hydroxysafflower yellow A for injection 50mg & 100mg
Multiple-dose group:Hydroxysafflower yellow A for injection 75mg
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Gender: In the formal experiment, the number of healthy volunteers in each group of men and women is =3. 2. Age: 18 to 45 years old, inclusive of boundary values. 3. Weight: Female subjects should have a weight of =45kg and male subjects should have a weight of =50kg, with a body mass index (BMI) within the range of 19.0~27.0 kg/m2 [BMI=weight (kg)/height2 (m2)], including boundary values, for inclusion in the study. 4. Within the next 6 months, there are no plans for pregnancy, and the participant voluntarily agrees to take effective contraceptive measures during and within 6 months after the period of study and drug administration. 5. All subjects must be fully informed and agree to the trial before the experiment, fully understand the trial content, process, and possible adverse reactions, and voluntarily sign a written informed consent form. Test subjects must be able to communicate well with researchers and be able to complete the trial according to the protocol.
Exclusion criteria
Exclusion criteria: 1. To those who have a history of allergies to two or more types of drugs, or to those who are known to have allergies to this product or its excipients. 2. Any past or current medical history that may affect the safety of the trial or the drug metabolism process, including but not limited to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, mental and nervous system, otolaryngology related diseases, especially those who suffer from any disease that increases the risk of bleeding. 3. Screen out those who have risk factors for advanced torsades de pointes ventricular tachycardia, including short QT syndrome, long QT syndrome, unexplained sudden death under the age of 40, drowning, or sudden infant death syndrome in first-degree relatives (i.e. biological parents, siblings or children). 4. Screen out those who are hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia. 5. Before administering the medication, a comprehensive physical examination, a 12-lead electrocardiogram, vital signs measurement (including temperature, blood pressure, respiratory rate, and pulse rate), eye examination (to check for bleeding), chest X-ray in an upright position, and laboratory tests (including blood biochemistry, blood routine, urine routine, stool routine and occult blood test, immunology panel, coagulation function, platelet aggregation test, and female pregnancy test) should be conducted within 7 days. Any abnormalities with clinical significance should be determined by the attending physician. 6. Screening individuals who have received major surgery within the first 6 months or those who are planning to undergo surgery during the study period. 7. Screen out those who have a history of drug abuse or drug addiction, or who have tested positive in a urine screening for drug abuse (including morphine, methylamphetamine, and ketamine). 8. Screen for individuals who, on average, smoked more than five cigarettes per day during the previous three months, or who refuse to refrain from using tobacco products during their hospital stay. 9. Screen out individuals who have consumed alcohol frequently in the past 6 months, meaning those who consume more than 14 units of alcohol per week (1 unit = 360mL of beer containing 5% alcohol content, or 45mL of liquor containing 40% alcohol content, or 150mL of wine containing 12% alcohol content), or those who were unable to stop alcohol intake during the study period. 10. Screen out those who have donated blood or suffered significant blood loss (=300mL, excluding women during menstruation) within the previous 3 months, or those who have used blood products or received blood transfusions. 11. Screen out those who had taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within the past two weeks. 12. Screen out those who has special dietary requirements, cannot follow a unified diet. 13. Screen out pregnant and lactating women 14. Screen out those who have participated in other clinical trials within the past three months. 15. Researchers believe that participants have other factors that make them unsuitable for participating in this experiment (such as inability to understand study requirements, difficulty with venipuncture, poor compliance, the presence of factors that affect completing this study, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;T1/2;Vd;CL;MRT0-8;AUC0-t;AUC0-8;AUMC0-t;AUMC0-8; | — |
Countries
China
Contacts
Public ContactHaiyan Li
Peking University Third Hospital
Outcome results
None listed