| Eligibility |
Inclusion Criteria:
- Healthy males, 18 to 45 years at the time of screening.
- Weight>50 kg, Body mass index (BMI) is 19~26 kg/m2
- signing of informed consent
- Volunteers are able to communicate well with the investigators and be able to complete
the trial according to the process
Exclusion Criteria:
- physical examination, vital signs, routine laboratory tests 12-lead ECG, Chest X-ray
,ophthalmologic examination, abdominal B-ultrasound and other abnormalities and
clinical significance.
- positive testing for HIV, HBsAg, HBeAb, HCVAb or Syphilis antibody.
- C- reactive protein (CRP) abnormalities are clinically significant or New Coronavirus
nucleic acid positive.
- Screening for use of any clinical trial drug within the first 3 months or withdrawal
time shorter than the 7 half-life period of the trial drug at enrollment, whichever is
the longest of the two;
- CYP3A4, CYP2C8 , CYP2C9 and p-gp inducers or inhibitors were taken within 28 days
before screening
- Use of any prescription or over-the-counter drug, any vitamin product, health care
drug or Chinese herbal medicine within 14 days prior to screening;
- clinical symptoms or diseases of the heart;supraventral or ventricular arrhythmia with
clinical significance that requires treatment or intervention; QTcF>450ms at screening
stage
- Patients who had undergone major surgery or whose surgical incision was not completely
healed within 6 months before the screening period;Major surgery includes, but is not
limited to, any surgery with a significant risk of bleeding, prolonged general
anesthesia, or an open biopsy or significant traumatic injury;
- Significant clinical bleeding symptoms or definite bleeding tendency occurred within 3
months before screening
- Screening for abdominal fistula, gastrointestinal perforation or abdominal abscess in
the first 6 months;
- Hemorrhoids or perianal diseases with regular/bleeding in the stool;Patients with
gastrointestinal dysfunction, such as irritable bowel syndrome and inflammatory bowel
disease, may be affected by drug absorption as determined by researchers;
- Allergic persons,
- A history of any clinically serious illness or condition, including but not limited to
circulatory, endocrine, nervous, digestive, urinary, or blood, immune, mental, and
metabolic diseases, that the investigator considers to be likely to affect the results
of the study;
- Habitual constipation or diarrhea;
- Heavy drinking or regular drinking in the six months preceding the screening period
- Those who had smoked more than 5 cigarettes per day on average in the 3 months before
the screening period or habitually used nicotine-containing products and were unable
to quit during the test period;
- Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the
screening period or use of hard drugs (e.g., cocaine, amphetamines,
phenylcyclohexidine, etc.) in the 1 year prior to the screening period;Or screening
for positive urine drug abuse (drug) tests;
- habitual consumption of grapefruit juice or excessive consumption of tea, coffee
and/or caffeinated beverages and failure to abstain during the study period;
- Those with a history of fainting needle or blood, have difficulty in blood collection
or cannot tolerate vein puncture for blood collection;
- Workers engaged in conditions requiring long-term exposure to radioactivity;Or have
significant radiation exposure (=2 chest/abdomen CT, or =3 other types of X-ray
examinations) within 1 year before the test or have participated in the
radiopharmaceutical labeling test;
- Those who have lost blood or donated up to 400 mL within 3 months before the screening
period, or those who have received blood transfusion, or those who plan to donate
blood within 3 month after the end of this test;
- Those who have been vaccinated within 1 month before screening or those who plan to be
vaccinated during the trial period;
- Having family planning during the trial period and within 12 months after the last use
of the drug, or not agreeing that subjects and their spouses should take strict
contraceptive measures during the trial period and within 12 months after the last use
of the drug;
- As determined by the investigator, the subject has other factors that are not suitable
for the study.
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