Peptic ulcer
Conditions
Interventions
Cases:20mg/100uCi [14C] KFP-H008 liquid medicine, single oral dose
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Gender: Healthy male subjects who have no childbearing plans during the study and within 1 year after the study ends, and both of them and their sexual partners take effective contraceptive measures; 2. Aged 18 to 50 years, inclusive, at the time of signing the informed consent form; 3. Total body weight: Total body weight >=50.0kg for males and body mass index (BMI) 18 to 26 kg/m2 (including 18.00 and 26.00); 4. Subjects must give informed consent to this study prior to the trial, and sign a written informed consent form voluntarily; 5. No clinically significant abnormal vital signs, physical examinations, laboratory examinations, electrocardiograms, chest radiographs and other examination results at screening; 6. Subject have a good hygiene habit and can communicate well with the investigator and complete the study in accordance with the study regulations.
Exclusion criteria
Exclusion criteria: 1. Subjects who have had a clinically significant disease or have undergone surgery within 3 months before the administration; 2. Subjects who have had a history of severe allergies or are suspected of being allergic, or allergic to the investigational product or any of its excipients; 3. Subjects who have any history of serious clinical diseases or diseases or conditions that the investigator believes may affect the results of the study, including but not limited to those with a history of circulatory, endocrine, neurological diseases or hematology, immunology, psychiatric diseases and metabolic abnormalities; 4. Subjects who have had gastrointestinal, liver, and kidney diseases that can affect drug absorption or metabolism within 3 months prior to screening, such as habitual constipation or diarrhea, irritable bowel syndrome, etc; 5. Laboratory tests (blood routine, urine routine, blood biochemistry, stool routine test, etc.) found to have abnormal clinical diagnostic significance; 6. Suffer from hemorrhoids, or positive fecal occult blood test at screening/baseline; 7. Subjects who have difficulty in blood collection or venipuncture; 8. Subjects whose liver function test indicators are out of the normal range; 9. Abnormal ECG (with clinical significance) or abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; pulse 100 bpm); 10. Subjects who test positive at screening for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, Treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody; 11. Alcoholics or subject who consumes excessive amounts of alcohol within 6 months prior to the study, defined as greater than 14 units per week (1 units = 360 ml beer or 45ml spirits with 40% alcohol or 150ml wine), or subject whose alcohol breath test is positive at baseline; 12. Smokers or subjects who have smoked more than 1 cigarette a day within 3 months prior to the study, or use any tobacco products during the study; 13. Drug abusers or those who have used soft drugs (e.g. marijuana) 3 months prior the study or hard drugs (e.g cocaine, phencyclidine, etc.) 1 year prior to the study, or those who have a positive urine drug abuse screening test; 14. Subjects who are allergic to any food or have special dietary requirements and cannot follow a unified diet; 15. Subject consumes excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups) per day and cannot stop using them during the study period; 16. Subjects who have taken any medication within 14 days prior to the study administration; 17. Subjects who have used any drugs that inhibit or induce liver metabolism 30 days prior to or during the study (e.g. inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 18. Subjects who have taken any clinical trial drug within 3 months prior to the trial administration or the drug withdrawal time is shorter than the 6 half-life of the trial drug at the time of enrollment (Whichever of the two has the longest time shall prevail), Or those who participated in and took radiolabeled clinical trial drugs within 1 year prior to administration; 19. Blood donation or haemorrhage within 3 months prior to the study administration (=400mL); 20. Significa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;Cumulative drug excretion;Metabolite identification;Pharmacokinetic parameters of unlabeled KFP-H008 and metabolite M9; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;Laboratory examination;vital signs;12-lead ECG;Physical examination; | — |
Countries
China
Contacts
Public ContactFeng Shao/Wei Liu
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed