Mass Balance Study of [14C] TJ0113 in Healthy Chinese Subjects

You may not qualify if:

• Auxiliary examination:
• Subjects who have abnormal and clinically significant results of comprehensive physical examination, digital anal examination, laboratory tests (hematology, blood chemistry, coagulation function, urinalysis, stool routine + occult blood, thyroid function), 12-lead ECG, ophthalmic examination (slit-lamp, intraocular pressure and fundus radiography), chest X-ray (anteroposterior) and abdominal B ultrasound (liver, gallbladder, pancreas, spleen and kidney);
• Subjects with unqualified vital signs that remain unqualified upon retesting;
• Subjects who have a resting corrected QT interval (QTcF) \> 450 ms (corrected according to Fridericia's formula) or QRS \> 120 ms as determined by 12-lead electrocardiogram (ECG), or a previous history of long QT syndrome;
• Subjects who have any clinically significant abnormality in hepatitis B surface antigen, hepatitis B E antigen, hepatitis C virus antibody (anti-HCV), treponema pallidum antibody test, and human immunodeficiency virus antibody (anti-HIV) as judged by the investigator;
• Medication History:
• Subjects who use any drug inhibiting or inducing hepatic drug-metabolizing enzyme activity (see Appendix 1 for details) within 30 days before screening;
• Subjects who use any prescription drugs, over-the-counter drugs, Chinese herbal medicines and food supplements (such as vitamins and calcium supplements) from 14 days before screening to predose;
• Disease and Surgical History:
• Subjects who have febrile illness or active infection within 14 days before screening;
• Subjects who have gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea or malabsorption syndrome, or a history of severe vomiting or diarrhea within one week before screening;
• Subjects who have a history of any clinically significant disease or any disease or condition that may affect the study results in the opinion of the investigator, including but not limited to cardiovascular system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases;
• Subjects who have dysphagia or any condition that may affect oral administration and drug absorption (e.g., cholecystectomy, gastric bypass, duodenotomy, colectomy, post-gastrointestinal resection, ulcerative colitis, symptomatic/inflammatory bowel disease, intestinal obstruction, etc.);
• Subjects who have undergone major surgery within 6 months before screening or have incomplete healing of surgical incision, including but not limited to any surgery with significant bleeding risk, prolonged general anesthesia, or incisional biopsy or significant traumatic injury; or who have undergone surgery affecting drug absorption, distribution, metabolism, excretion, or plan to undergo surgery during the study period;
• Subjects who have drug, environmental, food allergy or allergic constitution, or may be allergic to the investigational product judged by the investigator;
• +17 more criteria