| Eligibility |
Inclusion Criteria:
1. Able and willing to give written informed consent before study, and fully understand
the study content, process and possible adverse reactions;
2. Able to complete the study in compliance with the protocol;
3. Subject (including partner) is willing to voluntarily take effective contraceptive
measures from screening through 90 days after the last dose of study drug (see
Appendix 5 for details);
4. Male and female subjects between the ages of 18 and 65 years, inclusive;
5. At least 50 kg for male subjects, 45 kg for female subjects, with a Body Mass Index
(BMI= Weight/Height2) between 18-32 kg/m2, inclusive;
6. With normal or clinically insignificant abnormal results of physical examination and
vital signs test;
7. Subjects will be assigned into the group according to the CYP2C19 genotype: the first
group of ultra-rapid metabolizers (CYP2C19*17/*17); the second group of rapid
metabolizers (CYP2C19*1/*17); the third group of normal metabolizers (CYP2C19*1/*1);
the fourth group of intermediate metabolizers (CYP2C19*1/*2, *1/*3, *2/*17, *3/*17);
and the fifth group of poor metabolizers (CYP2C19*2/*2, *2/*3, *3/*3).?
Exclusion Criteria:
1. More than 5 cigarettes per day on average within 3 months before the study;
2. History of sensitivity to drugs similar to the study drug or have high sensitivity to
clopidogrel, allergic constitution (e.g. allergy to various drugs and foods);
3. History of drug abuse, drug use, alcohol abuse (14 units of alcohol per week: 1 units
= 285 mL beer, 25 mL spirit or 100 mL wines);
4. Donation or loss of a significant volume of blood (> 450 mL) within 56 days prior to
screening;
5. Intake of any prescription drugs, over-the-counter drugs, vitamin or herbal medicine
within 14 days prior to receiving study drug;
6. Consumption of any special diet (such as grapefruit, pitaya, mango, pomelo, etc.) or
subjects have engaged strenuous exercise or any other factors affecting drug
absorption, distribution, metabolism and excretion within 14 days prior to receiving
study drug;
7. Intake of any drug which Have taken strong inhibitors and/or inducers of liver
metabolic enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4 and 3A5) within 28 days before the
first medication, and strong inhibitors of liver metabolic enzymes such as:
ciprofloxacin, clopidogrel, Itraconazole, ketoconazole, ritonavir, troleandomycin,
etc., strong inducers of liver metabolism enzymes such as: rifampicin, carbamazepine,
phenytoin sodium, St. John's wort, etc.(For details see Appendix 6);
8. Recent major changes in diet or exercise habits;
9. Use of an investigational drug or product, or participation in a drug research study
within 30 days (or 5 half-lives) prior to receiving study drug;
10. History of difficulties in swallowing, or any gastrointestinal disease which could
affect the drug absorption;
11. Suffering from any diseases that may increase the risk of bleeding, such as
hemorrhoids, acute gastritis, stomach and duodenal ulcers, Thrombocytopenic Purpura
and hemophilia, etc;
12. Family history of coagulation or bleeding disorders (e.g., hemophilia)/symptoms (e.g.,
vomiting blood, black stools, severe or recurrent nosebleeds, coughing up blood,
significant hematuria, or intracranial hemorrhage) or suspected vascular
malformations, such as aneurysms or early onset strokes, in the individual or in their
immediate family;
13. A clinically significant 12-lead ECG abnormality;
14. Positive test results of blood pregnancy or subject is lactating for female subjects;
15. Any clinically significant abnormalities/findings in laboratory tests, or any
clinically significant disease including but not limited to gastrointestinal, renal,
hepatic, neurological system, blood, endocrine, tumor, lung, immune, mental, or
cardiovascular and cerebrovascular diseases;
16. Positive test results for viral hepatitis (including hepatitis B and C), HIV antibody
or syphilis antibody;
17. Acute illness or concomitant medication from screening to the first dosing of study
medication;
18. Consumption of chocolate or any food or beverages containing caffeine or (rich
containing) xanthine within 48 h prior to receiving the first dosing of study
medication;
19. Consumption of any product containing alcohol within 24 h prior to receiving the first
dosing of study medication, or positive results from a screen for alcohol;
20. Positive results from a screen for urine drug test (Morphine, marijuana);
21. Subjects were vaccinated within 4 weeks prior to screening, or planned to be
vaccinated during the trial;
22. Any condition which in the opinion of Investigator is not suitable for subjects to
participate in the study (For ultra-rapid metabolizers and rapid metabolizers,
investigators may consider at their discretion).
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