Healthy tolerance
Conditions
Interventions
Test drug group:Ulinastatin for Injection
control:Ulinastatin for Injection
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Gender:Chinese healthy adult volunteers,male or female; 2. Aged between 18 to 50 years, no more than about 10 years old in same group; 3. Weight: more than 50 kg, and body mass index of 19-24; 4. No allergic history, especially no food and drug allergy by requesting; 5. No fainting of injection or blood history; 6. No significant evidence or abnormal finding in medical history, clinical checks, lab results, 12-lead electrocardiograms (ECGs), X-ray film of chest radiography during the screening period; 7. No abnormal finding history in heart, kidney, digestive tract, nervous system, metabolism system and so on; 8. No other drugs during past 4 weeks; 9. No drug dependency and NO smoking and alcohol addiction by requesting; 10. No abdominal pain, diarrhea and other Gastrointestinal symptoms during past 3 weeks; 11. Make sure subjects take effective contraception during the study and 3 months after the study; 12. All subjects understand the study and possible adverse reactions, volunteered to attend this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Have any significant cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine and metabolic, hematologic, neurologic, or psychiatric and other diseases; 2. Have history of bronchospasm; 3. Have history of drug abusing by requesting; 4. Have an allergic constitution, or have allergic history on drug,food by requesting; 5.Smoke 5 cigarettes or same amount of tobacco by requesting; 6.Drinking 28 units alcohol everyweek (1 units=285ml beer or 25ml spirits or 1 glass of wine) by requesting or drinking before 48 hours or during the study, or drinking in 24 hours and alcohol test is positive; 7. Taken any drug during the past 4 weeks; 8. Donated blood or loss blood (1 unit or 350ml) during the past 3 months; if blood loss more than 200ml, the subject can be recruited in 60 days after the blood donated /loss; 9. Taken known drug damage on main organs during the past 3 months; 10. Attending on anther clinical study or attended it 3 month before this study; 11. Have abnormal lab results during screening period; 12. hepatitis positive, including hepatitis B surface antigen and anti-HCV antibody; 13. HIV or syphilis positive; 14. HCG test positive (blood HCG or urine HCG); 15. Menstrual,pregnancy or breast-feeding; 16. Subject cannot understand the scheme or cannot communicate or cooperate with researches; 17. Considered not fit to attend this study on other factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety tolerabilit; | — |
Countries
China
Contacts
Public ContactFang Yi
Outcome results
None listed