| Eligibility |
Inclusion Criteria:
1. Healthy male adults;
2. 18 to 45 years (inclusive);
3. Subjects weight =50.0 kg and body mass index (BMI) between18-26 kg/m^2 (inclusive)
(BMI= weight (kg)/height^2 (m^2);
4. Medical history, vital signs examination, physical examination, laboratory tests
(blood routine, blood biochemistry, urine routine, thyroid function) and other test
results of subjects judged to be normal or abnormal without clinical significance;
5. Voluntarily sign the informed consent form, understand the trial procedures, and be
willing to comply with all trial procedures and restrictions.
Exclusion Criteria:
1. Clinically significant abnormal results for physical examination, vital signs, routine
laboratory tests (blood routine, blood biochemistry, coagulation routine, urine
routine, stool routine + occult blood, thyroid function, glycated hemoglobin), 12-lead
electrocardiogram (ECG), chest CT scan, and abdominal B-ultrasound (liver,
gallbladder, pancreas, spleen, and kidney);
2. Any positive test result of hepatitis B surface antigen, hepatitis C virus antibody,
anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific
antibody;
3. Subjects with a history of severe hypoglycemia, such as drowsiness, disturbance of
consciousness, or even coma due to hypoglycemia;
4. History of acute and chronic pancreatitis, or a history of cholecystitis, gallstones,
and pancreatic injury and other high-risk factors that may cause pancreatitis;
5. Subjects are hard to swallow, or have diseases affecting drug absorption,
distribution, metabolism, excretion;
6. History of gastrointestinal ulcer or bleeding;
7. History of any clinically significant diseases, such as circulatory, endocrine,
neurological, gastrointestinal, urinary, hematological, immunological, psychiatric and
metabolic diseases;
8. History of organic heart disease, heart failure, myocardial infarction, angina
pectoris, unexplained arrhythmia, torsade de pointes ventricular tachycardia,
ventricular tachycardia, prolonged QT syndrome, or symptoms of prolonged QT syndrome
and family history;
9. Have a major surgery or incomplete incision healing within 6 months prior to
screening. Major surgery includes, but is not limited to, any surgery involving a
significant risk of bleeding, prolonged general anesthesia, or open biopsy or obvious
traumatic injury;
10. History of needle sickness or blood sickness, difficulty in blood collection or
intolerance to venipuncture blood collection;
11. Have hemorrhoids or perianal disease with regular/ongoing bleeding stools;
12. Have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel
disease;
13. Have a history of allergic conditions, or have a history of allergy to any of DBPR108
or other similarly structured drugs. Those who cannot follow a uniform diet.
14. Subjects are lactose intolerant or have rare genetic galactose intolerance, Lapp
lactase deficiency, or glucose-galactose malabsorption;
15. Use of any metabolizing enzyme inducers or inhibitors within 30 days prior to
screening;
16. Use of any prescription drug, over-the-counter drug, proprietary Chinese medicine,
herbal medicine, vitamins and supplements within 2 weeks prior to screening;
17. Have been vaccinated within 4 weeks prior to screening or who have a scheduled
vaccinated plan during the study period;
18. Participation in another clinical trial within 3 months before screening (whichever is
administrated);
19. Average weekly intake of alcohol is more than 14 units alcohol (1 units ˜ 360 mL beer,
or 45 mL spirits with 40% content, or 150 mL wine) within the 6 months prior to
screening, or a positive ethanol breath test at screening;
20. Smoking more than 5 cigarettes per day within 3 months prior to screening, or who
cannot stop using any tobacco products during the study period;
21. History of drug abuse, or positive urine drug screen at screening;
22. Subjects who have a habitual consumption of grapefruit juice or excessive amounts of
tea, coffee and/or caffeinated beverages (such as coffee, tea, cola, chocolate, energy
drinks), and unable to quit during the study period;
23. Workers engaged in long-term exposure to radioactive conditions, or have had
significant radiation exposure (=2 chest/abdominal CT scans, or =3 other types of
X-rays) or participated in the radiopharmaceuticals labeling test within 1 year prior
to the study;
24. Subjects who have fertility or sperm donation plans, or do not agree to use strict
contraceptive methods during the study period and within 1 year after the completion
of the study;
25. Blood donation (or blood loss) =400 mL within 3 months, or receiving whole blood
transfusions or erythrocyte suspension transfusions within 1 month prior to the
screening;
26. Not suitable for this study as judged by the investigator.
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