| Eligibility |
Inclusion Criteria:
- Voluntary signing of informed consent before the trial, and full understanding of the
experimental content, process and possible ARs;
- Able to complete the study according to the protocol;
- Subjects (and their partners) are willing to take effective contraceptive measures
from screening to 6 month after the last dose of the IMPs. See Appendix 5 for specific
contraceptive measures;
- Male and female subjects aged 18 to 45 years (inclusive);
- Male weight =50 kg, female weight = 45 kg. Body mass index (BMI) = body weight (kg) /
height2 (m2). BMI ranging from 18 to 28 kg/m2 (including critical values);
- Physical examination and vital signs are normal or abnormal without clinical
significance.
Exclusion Criteria:
- More than 5 cigarettes per day on average 3 months before the trial;
- Allergic constitution (allergic to multiple drugs and foods), or known to be possibly
allergic to drugs of the same class of the IMP or highly sensitive to clopidogrel;
- History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25
mL of spirits, or 100 mL of wine); history of drug abuse or use of hard drug within
the past five years;
- Blood donation or massive blood loss (>450 mL) within 3 months before screening;
- Presence of dysphagia or history of any gastrointestinal and hepatic, renal disease
(whether cured or not) or history of surgery that affects absorption or excretion of
the IMP within 6 months prior to screening;
- With any disease that increases the risk of bleeding, such as acute gastritis, stomach
and duodenal ulcers, or history of abnormal bleeding (e.g. bleeding time prolonged
after tooth extraction);
- The subject or his or her immediate family member has a family history of coagulation
or haemorrhagic disorders (such as haemophilia)/symptoms (such as hematemesis, melena,
severe or recurrent epistaxis, coughing blood (hemoptysis), obvious hematuria or
intracranial hemorrhage), or suspected vascular malformation, such as aneurysm or
early-onset stroke;
- Took potent inhibitors and/or inducers of CYP enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4 and
3A5) within 28 days prior to the first dose. Potent inhibitors of CYP enzymes include
ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, troleandomycin,
etc.. Potent inducers of CYP enzymes include rifampicin, carbamazepine, phenytoin
sodium, St. John's wort, etc.. See Appendix 6 for details;
- Took any prescription, non-prescription, any vitamin or herbal drugs within 14 days
before the first dose;
- Had foods that affect CYP3A4 metabolism within 2 weeks prior to the first dose, such
as grapefruit or grapefruit-containing beverages, or had intense physical exercise
(e.g. strength training, aerobic training, and playing football) within 7 days prior
to the first dose, or other factors affecting drug absorption, distribution,
metabolism, excretion, etc.;
- Recently there have been major changes in diet or exercise habits;
- Participated in a another clinical study within 3 months prior to screening (a subject
may be enrolled if he/she withdraws from the study prior to treatment, i.e., the
subject is not randomized or doesn't receive treatment);
- Failure to tolerate high-fat meals (two boiled eggs, one slice of toast with butter
and bacon, a box of French fries, a glass of whole milk);
- 12-lead ECG abnormalities have clinical significance;
- Female subjects who are in lactation or positive for serum pregnancy test in the
screening period or during the trial;
- Clinical laboratory abnormalities have clinical significance or other clinically
significant diseases before screening (including but not limited to gastrointestinal,
kidney, liver, nerve, blood, endocrine, tumor, and lung, immune, mental or
cardiovascular and cerebrovascular diseases);
- Positive for viral hepatitis (including hepatitis B and C), HIV antibody and treponema
pallidum antibody during screening;
- Any acute diseases or concomitant medicines from screening period to before taking the
IMPs;
- Took chocolate, any food or drink with caffeine or xanthine within 24 hours before the
first dose;
- Took any alcoholic product or alcohol breath test is positive within 24 hours before
the first dose;
- Urine drug screening positive;
- The investigator believes that there are other factors that are not suitable for
participating in the trial.
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