anticoagulation
Conditions
Interventions
Experimental Group versus Reference Group:Nadroparin calcium for Injection versus Nadroparin calcium Injection
Sponsors
Beijing Anzhen Hospital Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Gender: male. 2. Age18 ~ 40 years old,. 3. Weight:50~70 kg. 4. BMI:19.0~26.0 kg/m2,Including boundary value. 5. Fully understand the benefit and potential riskof the study ,and signinformed consent form before participating in the study, 6. Has clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis),ECG and chest X-ray within the reference range for the testing laboratory at Screening or the results are deemed not clinically significant for inclusion into this study by the investigator.
Exclusion criteria
Exclusion criteria: 1. Cardiovascular, endocrine, neurological, respiratory, hematologic, immunology, psychiatric, metabolic, coagulopathyand others events. 2. History of bleeding or bleeding risk (such as gastric and duodenal ulcer, thrombosis related diseases, thrombocytopenia and platelet defects, serious diseases of the blood coagulation system, retinal vascular disease, etc.); 3. Previous history of alcoholism or tobacco, drug dependency, drug abuse or habitual psychoactive drugs consumption (more than 10 cigarettes a day, or the same amount of tobacco smoking.Drinking more than 28 units of alcohol a week (1 = 285 ml beer or 25 ml liquor or 1 glass of wine)); 4. Allergy to two or more drugs or food allergy or known main ingredients of this drug and excipients have allergies; 5. Participation in any other clinical trial within 30 days before start of the screening period; 6. Blood donation inthe pastfour weeks; 7. Major surgery in the past four weeks; 8. Use of any medication in the two weeks before the study; 9. Positive serology for HIV, HBsAg, HCV and syphilis; 10. Cannot follow the clinicians and investigator requirements (such as smoking, drinking and/coffee and juice); 11. Investigator self and his/her family members; 12. Other reasons which investigator consider not appropriate for inclusion(Such as the weak and so on).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacodynamics;bioequivalence;bioequivalence;pharmacokinetics profiles of the Nadroparin calcium Injection (PK of Anti?a factor, PK of Anti IIa factor); | — |
Countries
China
Contacts
Public ContactYang Lin
Outcome results
None listed