| Eligibility |
Inclusion Criteria:
- Healthy Chinese males, aged 18-45 years old (inclusive);
- Body weight = 50.0 kg, body mass index (BMI) between 19-26kg/m2 (inclusive);
- Sign the informed consent form;
- Participants 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,
abdominal B-ultrasound and other is abnormal and clinically significant;
- Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV
antibody, or Treponema pallidum antibodies;
- 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.
- Participants who have participated in any clinical trials within 3 months prior to
screening and have used the test drug or medical devices.
- 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.
- Participants who had heart disease such as heart failure, angina pectoris, myocardial
infarction, and clinically significant arrhythmia.
- Participants 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.
- Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6
months before screening.
- 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.
- Habitual constipation or diarrhea.
- Heavy drinking or regular drinking in the six months preceding the screening period,
or alcohol breath test results =20 mg/dL during the screening period.
- Participants 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.
- Participants 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 inthe
radiopharmaceutical labeling test.
- Having family planning during the trial period and within 1 year 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 1 year after the last use of
the drug.
- Participants who had lost blood or donated up to 400mL within 3 months before the
screening period, or Participants who had received blood transfusion, or Participants
who plan to donate blood within 3 month after the end of this test.
- As determined by the investigator, the subject has other factors that are not suitable
for the study.
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