Acute ischemic stroke
Conditions
Interventions
Single-administration group:On Days 1 and 11 of the trial, subjects shall orally take one tablet (10 mg) of rosuvastatin calcium on an fasted in the morning.
Combined-administration group:From Day 5 to Day 14, 40 mg of Y-3 for Injection shall be administered via intravenous infusion once daily in the morning for 10 consecutive days (with an infusion durati
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Participant fully understands the purpose, nature, procedures of the trial and potential adverse reactions, voluntarily participates in the trial, and a signed informed consent before performing any study-related procedures. 2. Healthy male or female participants aged 18 to 50 years (inclusive). 3. Male weight >= 50.0 kg, female weight >= 45.0 kg; Body Mass Index ranges from 19.0 to 26.0 kg/m^2 (inclusive). 4. Vital signs, physical examination, 12-lead electrocardiogram, abdominal ultrasonography (liver, gallbladder, pancreas, spleen and kidney), chest X-ray and laboratory examinations (blood routine, urine routine, blood biochemistry, coagulation function, four infectious disease markers, thyroid-stimulating hormone) are within normal ranges, or any abnormalities are judged to be clinically insignificant by the investigator. 5. Participants (including males) have no baby plan and willing adopt effective non-drug contraceptive measures from the signing of informed consent until 3 months after the last administration of the Investigational Product; meanwhile, they have no plan of sperm or oocyte donation. 6. Participants who able to communicate effectively with the investigator, understand and comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1. Participants with allergic diathesis, including allergic to drugs, food, pollen, etc., or with a history of allergy to rosuvastatin calcium, Y-3 for injection, or any of their components. 2. Participants who have disease history or current disease that may affect drug ADME or may affect the safety data, or may reduce treatment compliance, including but not limited to gastrointestinal, renal, hepatic, pulmonary, neurological, hematological, endocrine, neoplastic, immune, psychiatric, cardiovascular and cerebrovascular diseases (especially hepatic and renal insufficiency, and gastrointestinal disorders). 3. Participants with myopathy, myalgia or rhabdomyolysis. 4. Having received surgery within 6 months prior to the first dose of Investigational Product, or prior surgery that may affect drug ADME (e.g., cholecystectomy), or planning to receive surgery during the trial period. 5. Participants with a history of needle or blood phobia, intolerance to venipuncture or intravenous administration, or difficulty in blood sampling. 6. Participants who cannot follow the unified diet (e.g., special requirements for diet, intolerance to standard meals, hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption). 7. Creatinine Clearance (CrCl) 400 mL, excluding normal menstrual blood loss in females) within 3 months prior to the first dose; received blood transfusion or blood product infusion; or planning to donate blood or blood components during the trial or 1 month after trial completion. 10. Participants who have major changes in dietary or exercise habits within 3 months prior to the first dose. 11. Participants who smoke more than 5 cigarettes per day within 3 months prior to the first dose; or unable to refrain from smoking (including nicotine-containing smoking cessation products) within 48 hours prior to dosing and during the trial. 12. Participants with history of drug abuse or drug user within 6 months prior to the first dose; or positive urine screen for drugs of abuse (morphine, methamphetamine, ketamine, Tetrahydrocannabinolic acid, methylenedioxymethamphetamine). 13. Participants who drink more than 14 units of alcohol weekly within 3 months prior to the first dose (1 unit ˜ 360 mL beer / 45 mL 40% spirits / 150 mL wine); unable to refrain from alcohol and alcohol-containing products (including beverages and foods) within 48 hours prior to dosing and during the trial; or positive breath alcohol test (>0.0 mg/100 mL). 14. Participants who drink too much tea, coffee and/or caffeine-containing beverages daily (more than 8 cups, 1 cup = 250 mL) within 3 months prior to the first dose; or disagree that any caffeine-containing beverages (e.g., chocolate, coffee, tea, cola) are prohibited within 48 hours prior to dosing and during the trial. 15. Participants who have taken any drugs with potential interactions with the Investigational Product within 1 month p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t);Area under the plasma concentration-time curve from time zero to infinity (AUC0-8); | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax), time to reach maximum concentration (Tmax), terminal elimination half-life (t1/2z), elimination rate constant (?z), percentage of AUC extrapolated (AUC_%Extrap), apparent volume of distribution at terminal phase (Vz/F), and clearance (CLz/F);AUC0-t, Cmax, and Tmax of Y-3;Safety endpoints including adverse events, vital signs, physical examination, injection site reactions, laboratory tests, and 12-lead electrocardiogram results; | — |
Countries
China
Contacts
Public ContactZhou Huan
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed