Diabetic Kidney Disease, Amyotrophic lateral sclerosis
Conditions
Interventions
Test group:single dose of 600mg/100µCi [14C]TBN
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical research and sign the informed consent form, communicate well with the researchers and complete the entire research process according to the research requirements; 2. Healthy male subjects, 18-40 years old (including the boundary value), with normal bowel movements (1-2 times a day); 3. Weight >=50kg, body mass index (BMI) between 19.0~26.0kg/m2 (including boundary values); 4. Vital signs, physical examination, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, thyroid function, stool routine + occult blood, etc.), 12-lead electrocardiogram, chest X-ray (post-anterior) and other test results Normal or abnormal with no clinical significance; 5. Male subjects with reproductive potential must promise to have no parenting plan, no sperm donation plan and voluntarily take effective contraceptive measures (such as complete abstinence, taking condoms) within 6 months from the date of admission to the end of the study administration. , contraceptive sponge, contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptives, subcutaneous implants, etc.).
Exclusion criteria
Exclusion criteria: 1. Those with allergic constitution or allergic diseases, or those who are known to have a history of allergy to the components of the study drug, similar drugs or their excipients; 2. Those who have diseases that affect the absorption, distribution, metabolism, and excretion of oral drugs, as well as diseases that affect the evaluation of the efficacy and safety of the study drug, such as hemorrhoids or perianal diseases with regular or ongoing blood in the stool; 3. Peptic ulcer or bleeding in the past, any history of serious clinical diseases or diseases or conditions that the researchers believe may affect the results of the study, including but not limited to skin and mucous membranes, eyes, ear, nose and throat, circulatory system, endocrine system, respiratory system, nerve History of systemic, digestive, urinary or blood, immune, psychiatric and metabolic diseases; 4. Those who are positive for hepatitis B surface antigen HBsAg, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, and Treponema pallidum antibody; 5. Those who have undergone major surgery within 6 months before administration, or those who plan to undergo surgery during the study period; 6. Those who have a history of drug abuse, or who have used drugs within 3 months before administration, or who have positive urine drug abuse screening; 7. Those who smoke more than 10 cigarettes per day on average; 8. Frequent drinkers within 6 months before administration, that is, drinking more than 14 units of alcohol per week (1 unit = 360mL of beer or 45mL of spirits with an alcohol content of 40% or 150mL of wine), or a positive alcohol breath test By; 9. Those who have lost blood or donated blood >=400mL within 3 months before administration, or have received blood transfusion within 1 month; 10. Any drug that inhibits or induces liver drug metabolizing enzymes has been used within 30 days before administration (see Appendix 1 for details); 11. Those who have used any prescription drugs, non-prescription drugs, Chinese herbal medicines or food supplements, such as vitamins and calcium supplements within 14 days before administration; or have participated in clinical trials of other drugs and received experimental drugs within 3 months before the administration period ; 12. Those who have been vaccinated within 1 month before administration or who plan to be vaccinated during the study period; 13. Those with a history of fainting of needles or haemorrhage, difficulty in blood collection or inability to tolerate venipuncture for blood collection; 14. Workers who need to be exposed to radiation for a long time; or have significant radiation exposure (>=2 chest/abdominal CT, or >= 3 other types of X-ray examinations) within 1 year before administration, or have participated in radiopharmaceutical labeling experimenter; 15. The researcher believes that there are other factors that are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration of [14C]TBN; | — |
Secondary
| Measure | Time frame |
|---|---|
| plasma concentration o fmajor metabolites;Radioactive pharmacokinetics of [14C]-TBN; | — |
Countries
China
Contacts
Public ContactLiu Yanmei, Liu Gangyi
Shanghai Xuhui Central Hospital
Outcome results
None listed