Healthy tolerance
Conditions
Interventions
Test drug group:Ulinastatin
Control:Placebo
Sponsors
Shanghai Xuhui District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese male or female subjects, with good healthy condition screening by medical history, body check, vital sign, 12-lead electrocardiograms (ECGs), check radiography, lab results and other checks; 2. To be aged between 18 and 45 years; 3. Weight: more than 45kg, Body mass index more than 19 and less than 28kg/M2; 4. Subject can understand the program and the methods, and will follow this clinical scheme and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Smoke more than 5 cigarettes a day before screening; 2. Have drug abuse or alcohol abuse history 6 month before screening; 3. Have any severe disease or disease history in cardiovascular, hepatic, renal, gastrointestinal, respiratory,endocrine and metabolic, hematologic, neurologic, or psychiatric and other diseases; 4. Have Malignant neoplasm in any organ before the screening, no matter whether the neoplasm has been treated, recurrented or metastasized; 5. Have an abnormal electrocardiogram (ECG); 6. Have any disease history in cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, hematologic, neurologic, or other disease history that could affect drug absorbing, metabolism and clearance; 7. Have abnormal lab results; 8. Have disease history or evidence on renal inadequacy, e.g., Cr, usea nitrogen, usea, or other urea constitutional abnormal (e.g., proteinuria); 9. Have server disease or severe infection or injury in past 2 weeks before the study; 10. Have donated blood=400ML, or have severe lost blood=400ML in past 3 months; 11. Have an allergic constitution, or have allergic history on drug, or allergy to the test drug or the similar drug; 12. Have attended in other clinical study in past 3 months; 13. Have taken any Prescription Drug, OTC, herbs or food supplements (including vitamins), taken any drugs that would interrupt the data of this study, or taken any drugs or herbs that have toxicity to main organs; 14. Subject will be excluded if they are in pregnancies and breastfeeding periods or who has fertility and do not willing to do contraception measurement during the study; 15. HBV and HCV, HIV or syphilis positive; 16. Subject will be excluded if they are considered not to finish this study or they will bring obvious risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, tolerabilit; | — |
Countries
China
Contacts
Public ContactYu Chen
Outcome results
None listed