Acute coronary syndrome
Conditions
Interventions
Group A:Six subjects will be enrolled in the A dose group and randomized in a 2:1 ratio to either the trial drug group or the placebo group (i.e., 4 in the trial drug group and 2 in the placebo group)
Group B:Eight subjects will be enrolled in the A dose group and randomized in a 3:1 ratio to either the trial drug group or the placebo group (i.e., 6 in the trial drug group and 2 in the placebo grou
Group C:Eight subjects will be enrolled in the C dose group, and the first cycle will be randomized in a 3:1 ratio to either the trial drug group or the placebo group (i.e., 6 in the trial drug group
All 8 participants were given ticagrelor 180 mg PO as a single dose.
Group D:Eight subjects will be enrolled in the A dose group and randomized in a 3:1 ratio to either the trial drug group or the placebo group (i.e., 6 in the trial drug group and 2 in the placebo grou
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 ~ 45 years old, including the critical value; 2.Weight: male >=50kg, female >=45kg; Body mass index (BMI) in 19 ~ 26kg/m^2 (including boundary value), BMI = weight (kg)/height 2 (m^2); 3.Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, stool routine, blood biochemistry, blood transfusion four items, coagulation function), pregnancy examination (women of childbearing age), 12-lead electrocardiogram, results show no abnormality or abnormality is not clinically significant; 4.Male subjects and their partners or female subjects must agree to use one or more non-drug contraceptive methods (such as total abstinence, IUD, partner tying, etc.) during the trial period and for 3 months after the trial, and no sperm or egg donation plans; 5.The subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, voluntarily participate in the experiment and sign the informed consent; 6.The subjects were able to communicate well with the investigators and complete the study according to protocol.
Exclusion criteria
Exclusion criteria: 1.A person who is known to be allergic to ticagrelor or any component of the drug used in this study, or to one or more foods and drugs, or who is allergic; 2.The presence of medical history or evidence, including history of cardiovascular, nervous, respiratory, digestive, endocrine, immune, hematological, or any other systemic disease, that the investigator believes would interfere with the outcome of the clinical trial; 3.Have a bleeding tendency (such as recent trauma history, recent surgical history, coagulation dysfunction (such as hemophilia history), active or recent gastrointestinal bleeding), have a history of intracranial bleeding or other diseases that can change or increase the bleeding tendency (gastrointestinal ulcer, anaphylactoid purpura, lupus erythematosus, etc.); 4.Patients with a history of needle fainting or blood collection difficulties; 5.Patients with abnormal venous access or inability to tolerate venipuncture or dysphagia; 6.Patients who had undergone surgery within 3 months before the trial that the investigators judged would affect drug absorption, distribution, metabolism, and excretion; Or had surgery within 4 weeks prior to the trial, or planned to have surgery during the study period; 7.Alcohol breath test results greater than 0.0mg/100mL or drug abuse screening positive; 8.Have a history of drug abuse in the 6 months prior to screening or have used drugs in the 3 months prior to screening; 9.Systematic or topical use of prescription drugs, over-the-counter drugs, Chinese herbs or health products (vitamins or cod liver oil, etc.) within 2 weeks before screening; 10.Have used any CYP3A4 liver drug enzyme inhibitors, inducers or substrates or other drugs that interact with this product (e.g. Ketoconazole, clarithromycin, rifampicin, phenytoin, Cisapil, ergot alkaloids, simvastatin, lovastatin, digoxin, cyclosporine, etc.) in the 4 weeks prior to screening; 11.Use of peracetylsalicylic acid preparations, non-steroidal anti-inflammatory drugs (such as aspirin), P2Y12 receptor antagonists, or any other drug with anticoagulant activity (such as oral or injectable anticoagulants) in the 4 weeks prior to screening; 12.Those who smoked more than 5 cigarettes per day in the 3 months prior to screening, or could not stop using any tobacco products during the trial period; 13.Those who consumed an average of more than 14 units of alcohol per week (1 unit of alcohol ˜360mL beer or 45mL spirits with 40% alcohol content or 150mL wine) in the three months prior to screening, or could not abrol during the test period; 14.People who consumed xanthine-rich foods or beverages (such as tea, coffee, chocolate, or cola) within 24 hours prior to administration, or who ate grapefruit or drank grapefruit juice within 48 hours prior to administration; 15.Blood donation/blood loss of 400mL or more in the 3 months prior to screening, or blood transfusion/blood product users, except female menstrual blood loss; 16.Participants who have participated in clinical trials of other drugs or medical devices within 3 months prior to screening; 17.Acute or serious illness occurred between the screening and the use of the investigational drug product; 18.The female subject is pregnant or breastfeeding; 19.The researcher believes that there are any other people who are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital sign;Electrocardiogram change; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Pharmacodynamics; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital, Central South University
Outcome results
None listed