acute coronary syndrome
Conditions
Interventions
A:Ticagrelor 60mg in the first cycle, Ticagrelor 90mg in the second cycle, clopidogrel 75mg in the third cycle, and the cleaning period was 6 days.
B:Ticagrelor 90mg in the first cycle, clopidogrel 75mg in the second cycle, and ticagrelor 60mg in the third cycle, with a cleaning period of 6 days
C:Clopidogrel 75mg once in the first cycle, ticagrelor 60mg once in the second cycle and ticagrelor 90mg once in the third cycle. The cleaning period was 6 days
D:Clopidogrel 75mg once in the first cycle, ticagrelor 90mg once in the second cycle and ticagrelor 60mg once in the third cycle. The cleaning period was 6 days
E:Ticagrelor 90mg in the first cycle, Ticagrelor 60mg in the second cycle and clopidogrel 75mg in the third cycle, and the cleaning period was 6 days
F:Ticagrelor 60mg per dose in the first cycle, clopidogrel 75mg per dose in the second cycle and ticagrelor 90mg per dose in the third cycle. The cleaning period was 6 days
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all the following criteria will be admitted to this study: 1) Aged 18 to 55 years male and female equally; 2) The genotype was CYP2C19*1/*1; 3) Body weight of male subjects >=50 kg, body weight of female subjects >=45 kg, body mass index (BMI) between 19-26 kg/m2, including the critical value; 4) Subjects voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: Subjects meeting one of the following conditions will not be included in the study: 1) People who are suffering from any clinical serious diseases of circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormality, or any other diseases that can interfere with the results of the trial; 2) Have a history of allergy to medicine, food or other substances; 3) Patients with clinical pathologic active bleeding, especially those with peptic ulcer or intracranial hemorrhage or with a history of intracranial hemorrhage; 4) had surgery within 4 weeks prior to the study or planned to have surgery during the study period; 5) People who have taken any medicine or health care products (including Chinese herbal medicine) within 14 days before the trial; 6) Any drug used to inhibit or induce the liver to metabolize drugs (e.g., induction) during the 30 days before the trial; Barbiturates carbamazepine phenytoin glucocorticoids omeprazole inhibitors SSRI antidepressants cimetidine dithiazepide macrolide nitroimidazoles sedative hypnotic drugs verapamil fluoroquinolones antihistamines such as ketone, conazole, clarthromycin, nefazolidone, ritonavir and azanavir); 7) Participating in any clinical trial and using any investigational drug within 3 months prior to the trial; 8) Blood donation or massive blood loss (>=200 mL excluding menstrual blood loss in women) within 3 months before enrollment, receiving blood transfusion or using blood products; 9) Pregnant or lactating women and subjects who are unable to use one or more non-drug contraceptives during the study period; 10) People who have special requirements on diet and cannot follow the uniform diet; 11) Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups per cup = 250 mL) per day 12) Smokers or smokers who smoked more than 5 cigarettes per day during the first 3 months of the study or who could not stop using any tobacco products during the study; 13) Alcoholics or regular drinkers within 6 months prior to the study, i.e., those who consumed more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL 40% spirit or 150 mL wine) or who were unable to stop using any alcoholic products during the study period; 14) Drug abusers or users of soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phenylhexidine, etc.) within 3 months before the trial; 15) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure mmHg; Heart rate/pulse 100 BPM) or abnormal physical examination, electrocardiogram or laboratory examination with clinical significance (subject to clinician's judgment); 16) Subjects may be unable to complete the study for other reasons or the investigator considers that they should not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;Pharmacokinetic parameters;Pharmacodynamic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| CP-I, CP-III, GDF-15; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed