Cardiovascular disease
Conditions
Interventions
Single dose group of 3mg:3mg DT678 tablets or placebo
Single dose group of 6mg:6mg DT678 tablets or placebo
Single dose group of 9mg:9mg DT678 tablets or placebo
Single dose group of 12mg:12mg DT678 tablets or placebo
Single dose clopidogrel 75mg positive control group:clopidogrel 75mg
Single dose clopidogrel 300mg positive control group:clopidogrel 300mg
multiple dose group of 3mg:multiple dose of 3mg DT678 tablets or placebo
multiple dose group of 6mg:multiple dose of 6mg DT678 tablets or placebo
multiple dose clopidogrel positive control group:multiple dose of clopidogrel
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy participants aged 18 to 45 years (including threshold); 2. Male weight >= 50.0kg, female weight >= 45.0kg; Body mass index (BMI) is between 19.0 and 26.0 kg/m ^2 (including boundary values); 3. Previous medical history, vital signs, physical examination, clinical laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation function tests), 12 lead electrocardiogram, chest imaging, and other examinations are normal or abnormal without clinical significance; 4. The subjects and their partners were able to take effective contraceptive measures during the trial period and did not have any fertility plans during the trial period or within 6 months after the end of the trial; 5. The subjects have a full understanding of the trial content, process, and potential adverse reactions, and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of allergies to clopidogrel (as well as other thiophene pyridine drugs) or those who are allergic to any component of the investigational excipients or have an allergic constitution (such as allergies to two or more drugs, food, or pollen); 2. Individuals or their immediate family members have a family history of coagulation or hemorrhagic diseases (such as hemophilia)/symptoms (such as vomiting blood, black stools, severe or recurrent nosebleeds, hemoptysis, obvious hematuria or intracranial hemorrhage), or are suspected of vascular malformations, such as aneurysms or early-onset stroke; 3. Individuals who suffer from any clinically severe diseases such as respiratory, circulatory, digestive, urinary, hematological, endocrine, neurological, or psychiatric disorders, or have a history of these diseases or any other diseases or physiological conditions that can interfere with test results; 4. Any previous cause or disease that leads to thrombocytopenia, coagulation dysfunction, or bleeding tendency, including recurrent gum bleeding, peptic ulcers, severe or long-term heavy menstrual flow, urinary tract stones or hemorrhoids, etc; 5. Patients with lactose intolerance, or rare genetic diseases such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption (attention should be paid when screening only positive control subjects); 6. Those who have difficulty swallowing or have any diseases that affect drug absorption, distribution, metabolism, and excretion, as well as gastric motility and pH value (whether cured or not) or surgery (excluding appendectomy) within the first 6 months of screening, or who plan to undergo surgery during the study period; 7. History of drug abuse or positive drug abuse screening within the first 6 months of screening; 8. Individuals who have used long-acting estrogen or progesterone injections or implants within 6 months prior to the trial; Individuals who have used short acting contraceptives 30 days before the experiment; 9. Any drugs that inhibit or induce liver drug metabolism (such as inducers - rifampicin, barbiturates, carbamazepine, phenytoin, glucocorticoids; inhibitors - proton pump inhibitors, cimetidine, ketoconazole, opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors (SSRIs), antidepressants), have been used within 28 days prior to or during the screening period 5-hydroxytryptamine and norepinephrine reuptake inhibitors (SNRIs), antidepressants, macrolides, verapamil, diltiazem, quinolones, sulfonamides, etc; 10. Screening for individuals who have taken any prescription drugs, over-the-counter drugs, vitamin products, or traditional Chinese herbs within the first 2 weeks; Especially after receiving adenosine diphosphate receptor antagonists (clopidogrel and prasugrel), acetylsalicylic acid (aspirin), other NSAIDs drugs (ibuprofen, naproxen), GPIIb-IIIa receptor antagonists (acizumab and tirofiban, etc.), heparin, antibiotics (such as ß- Drugs that affect platelet function, such as lactam and cephalosporin antibiotics, SSRI antidepressants, etc; 11. Individuals who have a smoking habit within the first 3 months of screening (with an average of more than 5 cigarettes per day) or who have been selected but cannot stop using any tobacco products throughout the entire trial period; 12. Screening for individuals who have been addicted to alcohol within the first 3 months (consuming more than 14 unit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DT678 concentration in plasma;MP-H4 concentration in plasma;Clopidogrel concentration in plasma;Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Platelet aggregation rate;Platelet aggregation inhibition rate; | — |
Countries
China
Contacts
Public ContactWang Xinghe
10 Tieyi Road, Yangfangdian, Haidian District, Beijing, China
Outcome results
None listed