None listed
Conditions
Interventions
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
22 Years to 36 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects, male and female (both sexes), aged over 18 years old (including 18 years old); 2. The body weight of male subjects should be at least 50.0kg, and the body mass index (BMI) should be at least 19.0-26.0 kg/m2 (BMI= weight (kg)/height 2 (m2)) (including the cut-off value); 3. The subjects (including male subjects) are willing to have no plans to have children within 6 months from screening to the last dose of study drug, voluntarily take effective non-drug contraceptive measures (see the Appendix), and have no plans to donate sperm or eggs; 4. Sign informed consent before voluntary screening, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study in accordance with the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. The subject has diseases of the nervous/mental system, respiratory system, cardiovascular system, digestive system (any history of gastrointestinal diseases affecting drug absorption), blood and lymphatic system, urinary system, endocrine system, immune system, eye and skin; 2. Vital signs examination, physical examination, laboratory examination (blood analysis, urinalysis + urine sediment quantification, blood biochemistry, four coagulation tests, immune tests, blood pregnancy tests (female)), electrocardiogram, chest X-ray, and the results of abnormal clinical significance; (3) those who underwent surgery within 3 months before screening or planned to undergo surgery during the study, and those who underwent surgery that would affect drug absorption, distribution, metabolism, or excretion; 4. Allergic constitution or history of food or drug allergy, especially to any component of ondansetron and its excipients; 5. Those who had used any prescription drugs, over-the-counter drugs, Chinese herbal medicine or vitamins within 2 weeks before screening; 6. Participants who consumed an average of more than 14 units of alcohol per week in the 3 months before screening, or who could not abstain from alcohol during the study; 7. Who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the study; 8. Blood donation within 3 months before screening, including blood components or massive blood loss (=400mL) or blood transfusion history; 9. Those with a history of drug abuse within 6 months before screening; 10. Drug use within 3 months before screening; 11. Use of any drugs that inhibit or induce liver metabolism of drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors: SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 12. Those who had participated in other drug clinical trials within 3 months before screening or did not participate in clinical trials by themselves; 13. Received a vaccination within 1 month prior to screening (special: 1 month for adenovirus vector-based SARS-CoV-2 vaccine and 2 weeks for inactivated and recombinant vaccines), or plan to be vaccinated during the study period; 14. consuming excessive amounts of tea, coffee and/or caffeinated beverages (> 8 cups per day, 1 cup ˜250mL) in the 3 months before screening; 15. Those who have special requirements for diet and cannot accept a uniform diet; 16. Lactose intolerance (those who have had cow's milk diarrhea); 17. Patients with dysphagia; 18. Those who cannot tolerate venipuncture or have a history of syncope or blood; 19. The female subjects were lactating or had positive blood pregnancy test results; 20. If the investigator considers it inappropriate to participate in a clinical trial; 21. Had close contact with patients or suspected patients with confirmed novel coronavirus within 3 months before screening, or were themselves confirmed patients or suspected patients with novel coronavirus. 22. The result of alcohol breath test before admission was more than 0mg/100mL; 23. Patients with positive urine drug screening before admission; 24. Taking or drinking some fruit juice or cocoa or chocolate containing xanthine diet that may affect metabolism within 48 hours before admission;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2; | — |
Countries
China
Contacts
Public ContactMa Jie
Hebei General Hospital
Outcome results
None listed