Iron overload
Conditions
Interventions
2 Groups:Jiangsu Haosen Pharmaceutical Group Co., Ltd produced Tiralos tablet versus Novartis Pharma Stein AG produced Tiralos tablet
Sponsors
The First Affiliated Hospital, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years male and female; 2. Body mass index (BMI) = body weight (kg) / height 2 (M2), body mass index is in the range of 19.0-26.0 (including the critical value); male subjects' body weight >=50.0kg, female subjects' body weight >=45.0kg; 3. According to the past medical history, vital signs, comprehensive physical examination and specified laboratory tests, the researcher determined the healthy subjects; 4. Results of serum iron: 5.83-34.5 umol/L, total iron binding capacity 50.0-77.0 umol/L, total iron binding capacity >=15%; ferritin 7.0-323.0ng/ml; 5. Subjects (including male subjects) are willing to take effective contraceptive measures voluntarily without family planning from the screening date to 1 month after the last Administration (see Appendix 2 for detailed contraceptive measures); 6. The subjects must have informed consent to the study before the trial, and sign a written informed consent voluntarily; 7. The subjects were able to communicate well with the researchers and complete the research according to the research regulations.
Exclusion criteria
Exclusion criteria: 1. The physical examination, vital signs examination, 12 lead ECG or clinical laboratory examination are abnormal and have clinical significance; 2. Having a history of serious diseases such as heart, liver, kidney, endocrine, digestive tract, immune system and respiratory system, or having the above diseases, and judged by the researcher to have clinical significance; 3. Patients who have received surgery that may affect the absorption, distribution, metabolism and excretion of drugs are not suitable for the study; 4. Having a history of mental illness; 5. Prone to allergic reactions (such as skin rash, allergic reactions and angioneurotic edema); or known to be allergic to this product or any of its ingredients; 6. Those who had a history of drug use, drug abuse or drug dependence within 5 years before screening, or those who were positive in drug abuse screening; 7. Alcoholic or regular drinkers within 6 months before screening, i.e. the average weekly alcohol consumption is more than 14 units (1 unit = 285ml of beer or 25ml of spirits or 100ml of wine); 8. Those who are addicted to smoking or those who smoke more than 5 cigarettes per day on average within 3 months before screening; 9. Those who drank too much tea, coffee or caffeinated beverage (more than 8 cups, 1 cup = 250ml) every day within 3 months before screening; 10. Within 3 months before screening, blood donors or massive blood loss (> 400ml) or blood donation planners within 1 month after the end of the test; 11. Those who have used any prescription, over-the-counter or herbal medicine (except for external or local preparations) or vaccinated 14 days before taking the study drug; 12. UGT inducers (e.g. rifampin, phenytoin, phenobarbital, ritonavir) or any drugs that inhibit or induce liver metabolism (e.g. inducers - carbamazepine, glucocorticoid, Omeprazole; inhibitors - gefibezil, terfluramide, SSRI antidepressants, cimetidine, diltiazem, macrolides) were used within 30 days prior to administration of the study drug , nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 13. Those who have used bile acid chelators (such as coleenylamine, coleviron, coletipol) within 30 days before taking the study drug; 14. Those who had taken grapefruit and grapefruit drinks within 7 days before taking the study drug; 15. Have taken any alcohol containing products within 24 hours before taking the study drug, or have positive alcohol screening; 16. Those who participated in any clinical trial of drugs and used any clinical trial drugs within 3 months before screening; 17. Patients with acute disease at the pre study screening stage or before randomization; 18. Those who have special requirements for diet and cannot abide by the unified diet; 19. Dysphagia; 20. Those who can't tolerate venipuncture; 21. the female subjects were positive in lactation or pregnancy during screening or testing; 22. lactose intolerant; 23. subjects who may not be able to complete the study for other reasons or who are not suitable to participate in the study according to the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC;Cmax; | — |
Countries
China
Contacts
Public ContactJian Liu
The First Affiliated Hospital, Zhejiang University
Outcome results
None listed