Thromboembolic disease
Conditions
Interventions
A:30mgHY-021068 / placebo / 100mg positive drug
B:60mgHY-021068 / placebo / 100mg positive drug
C:115mgHY-021068 / placebo / 100mg positive drug
D:180mgHY-021068 / placebo / 100mg positive drug
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who met all of the following conditions entered the trial: 1) Gender: male or female; 2) Age: between 18 and 45 years old, the age difference between the same dose group does not exceed 15 years; 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 and 26 kg / m2, including the threshold value; 4) Volunteers signed a written informed consent.
Exclusion criteria
Exclusion criteria: Volunteers who meet one or more of the following criteria will be excluded: 1) Anyone who has suffered from any serious clinical disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or who can interfere with the test results Any other illness; 2) Have a history of allergies to drugs, food or other substances; 3) Those who have bleeding tendency, such as those that usually cause bleeding or subcutaneous bleeding due to mild collision; 4) Those who underwent surgery within 4 weeks before the trial, or plan to undergo surgery during the study period; 5) Those who have taken any drugs or health products (including Chinese herbal medicines) within 14 days before the test; 6) Any drug that inhibits or induces liver metabolism (eg: inducerbarbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole); inhibitorSSRI-type anti-inflammatory drugs Depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 7) Participated in any clinical trial and took any clinical trial drugs within 3 months before the trial; 8) Those who donated blood or lost a lot of blood ( >= 200 mL), received blood transfusion, or used blood products within 3 months before enrollment; 9) Pregnant or lactating women, and those who cannot use one or more non-drug contraceptives during a volunteer test; 10) Those who have special requirements on diet and cannot follow a unified diet; 11) Drink excessive amounts of tea, coffee and / or caffeinated beverages (8 cups or more, 1 cup = 250 mL) daily 12) Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the trial or who could not stop using any tobacco products during the trial; 13) Alcoholics or frequent drinkers within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of 40% spirits or 150 mL wine) or during Stop using any alcoholic products; 14) Drug abusers or those who used soft drugs (such as cannabis) 3 months before the test or who took hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test; 15) Those with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or abnormalities in physical examination, electrocardiogram, and laboratory examination have clinical significance Based on the judgment of the clinical research doctor); 16) Volunteers may not be able to complete the study for other reasons or those the investigator believes should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration;Urine drug concentration;Fecal drug concentration;Platelet aggregation inhibition rate; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed