Cardiovascular disease
Conditions
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects (aged 18-45 years),the age should not be more than 10 years old in the same batch; 2. Weight should be greater than 50 kg and BBMI in range of 19~24kg/m2 [BMI=weight (kg)/height 2(m2)], including boundary value; 3. agree to participate in the study and sign informed consent; 4. Be able to participate in the study until the completion of the study; 5. OATP1B1 genotypes conform to the requirements of the entry group.
Exclusion criteria
Exclusion criteria: 1. Any history of severe disease or medical history of the skin system, the central nervous system, the cardiovascular system, the kidney, the liver, the digestive tract, the lung disease, the metabolism, and the skeletal muscle system; 2. Specific allergic history (asthma, measles, eczema et.al); Allergic constitution: The persons allergy for investigator product, food, pollen or ingredients of investigator product (analogue); 3. Subjects who were given a course of treatment, including the use of non prescription drugs and Chinese herbs in the first two weeks of the trial, or those who had used the study drug in 4 weeks; or those who had used drugs that had known damage to the main organs within 3 months before the trial; 4. Participate other clinical trial in the last 3 months; 5. Blood donation or loss in the last 3 month; 6. who smoked 5 cigarettes per day (or the equivalent use of other nicotine containing products) 7. Frequently drinking 6 months before trial, averagely get above 28 units alcohol every week (1 unit=beer 285mL or 40% liquor 25mL or wine 150mL); 8. Whose baseline maximal platelet aggregation (MPA) response to 5 µM ADP of =70%; 9. Pregnant women, lactating women, menstrual women, children and the elderly; 10. Whose understanding, communication and cooperation are not enough, which can not guarantee comply with the study plan. 11. researchers believe there are other factors that are not suitable for participation in the trial; 12. Subjects who use the antiplatelet drugs and anticoagulants such as aspirin, ticker, warfarin, heparin or low molecular weight heparin, such as non steroidal anti-inflammatory drugs, corticosteroids, statins, calcium antagonists, and other related drugs within the first 4 weeks of the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma ticagrelor concentration ;Plasma AR-C124910XX concentration;Plasma AR-C133913XX concentration;Platelet aggregration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine ticagrelor concentration;Urine AR-C133913XX concentration;Urine AR-C124910XX concentration; | — |
Countries
China
Contacts
Public ContactShuaibing Liu
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed