Ischemic stroke and other thromboembolic diseases
Conditions
Interventions
300mg QD dose group:Subjects were randomized 1:1 to receive 300 mg, QD of the investigational drug, active drug, or placebo
300mg BID dose group:Subjects were randomized 1:1 to receive 300 mg, BID of the investigational drug, active drug, or placebo
Fasting administration-postprandial administration group:The first cycle was administered on an empty stomach (300mg, 240ml normal temperature water), and the second cycle was administered after meals
Postprandial administration-fasting administration group:The drug was given after the first meal (300mg, 240ml normal temperature water for 30min ± 2min after eating high fat and high heat breakfast)
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. No gender limit; 2. Aged between 18-45 years, the age difference of the same dose group is not more than 15 years old; 3. The weight of male volunteers is >=50.0 kg, the weight of female volunteers is >=45.0 kg, and the body mass index (BMI) is between 19-26 kg/m^2, including the critical value; 4. Volunteers voluntarily signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have suffered or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic abnormalities or any other disease that could interfere with the test results; 2. A history of allergies to drugs, food or other substances; 3. There is a tendency to bleed, such as bleeding or subcutaneous hemorrhage caused by mild collision; 4. Those who have undergone surgery within 4 weeks before the trial, or who plan to undergo surgery during the study; 5. Those who have taken any drugs or health products (including Chinese herbal medicine) within 14 days before the test; 6. Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before the test (eg: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 7. Those who participated in any clinical trial and took any clinical trial drug within 3 months before the trial; 8. Those who donated blood or lost a large amount of blood (>=200 ml), received blood transfusion or used blood products within 3 months before enrollment; 9. Pregnant or breastfeeding patients, as well as volunteers who cannot use one or more non-drug contraceptives during the trial; 10. Those who have special requirements for diet and cannot comply with the unified diet; 11. Those who drink too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 ml) every day; 12. Smokers or those who smoked more than 5 cigarettes per day in the first 3 months of the trial or those who could not stop using any tobacco products during the trial; 13. Heavy drinkers or regular drinkers in the 6 months preceding the trial, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of 40% alcohol or 150 ml of wine) or cannot stop using any alcohol-containing product during the trial; 14. Drug abusers or those who have used soft drugs (such as marijuana) in the 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) in the 1 year before the test; 15. Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or abnormal physical examination, electrocardiogram, imaging examination, and laboratory examination have clinical significance (subject to the judgment of the clinical research doctor); 16. Those who received inactivated vaccine within 1 month before screening, received live/attenuated vaccine within 3 months before screening or planned to receive inactivated/live/attenuated vaccine during the trial; 17. Patients may not be able to complete the study for other reasons or should not be included in the researcher's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamics;Vital signs;ECG monitoring;Laboratory examination;Adverse event;Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactYang Guoping, Huang Jie
Outcome results
None listed