Prevention and treatment of thromboembolism disseases
Conditions
Interventions
Fasting T-R group: Each participant will undergo the treatment of either test or reference products with a single subcutaneous dose under fasting conditions in each period.
Fasting R-T group:Each participant will undergo the treatment of either test or reference products with a single subcutaneous dose under fasting conditions in each period.
Sponsors
Henan (Zhengzhou)Zhonghui Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Able to give signed Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs); 2) Able to complete the trial in compliance with the protocol; 3) Participants (including males) willing to adopt effective contraceptive methods and with no pregnancy plan from 14 days before screening to 3 months after leaving the center; 4) Males and females between 18 and 55 years old, inclusive; 5) At least 60 kg for males, 50 kg for females, with a Body Mass Index (BMI) = Weight/Height2 (kg/m2) between 19.0-30.0 kg/m2, inclusive; 6) No history of cardiac, hepatic, renal, digestive tract, nervous system, mental and metabolic disorders, etc.
Exclusion criteria
Exclusion criteria: 1) With = 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial; 2) Allergic constitution or allergic to components of the drug and their analogs (such as enoxaparin, heparin or derivatives thereof, including other low molecular weight heparin), pork products, protamine or rubber; 3) A history of alcohol abuse (alcohol consumption of more than 14 units per week : 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine); 4) Blood donation or significant blood loss (=400 mL) within 3 months before the initial administration; 5) Any prescription medication within 14 days before the initial administration; 6) Any over-the-counter (OTC) medication or herbal medicine or health supplementary within 7 days before the initial administration; 7) Consumption of any special diets or food items (such as grapefruit), or strenuous exercise engagement, or other factors affecting drug absorption, distribution, metabolism and excretion within 7 days before the initial administration; 8) Participation in other drug clinical trials within 3 months before the initial administration; 9) Any clinically significant abnormality findings, as judged by a clinical physican, such as physical examination, vital signs, electrocardiogram and laboratory tests; 10) A history of known or suspected heparin-induced or otherwise thrombocytopenia; 11) A history of known or suspected heparin-induced or otherwise thrombotic complications; 12) A medical condition or history of significant active bleeding and a high risk of bleeding, such as hemorrhagic stroke, gastrointestinal ulcers, a malignant tumor with a high risk of bleeding, recent brain, spinal, or eye surgery, known or suspected esophageal varices, arteriovenous malformation, hemangioma, or major intraspinal or intracerebral vascular abnormalities; Or have bleeding tendency of organ damage; 13) Patients with acute infective endocarditis or history; 14) Participants with hyperkalemia or risk factors for elevated potassium, such as diabetes, chronic renal failure, metabolic acidosis, or taking medications known to increased potassium; 15) During screening creatinine clearance (CLcr) <80 ml/min ; 16) Positive results of hepatitis B surface antigen, hepatitis C antibody, and HIV antibody or syphilis; 17) Consumption of chocolate ,tea,cola or any food/beverage containing caffeine or rich in xanthine within 48 h before the initial administration; 18) Consumption of any products containing alcohol within 24 h before the initial administration, or a positive result of the alcohol breath test; 19) A positive result of the drug abuse test, or a history of drug abuse in the past 5 years, or intake of any narcotic drugs within 3 months prior to the trial; 20) A positive result of the pregnancy test, or in lactation during screening or the test period for female participants; Participants (or their partners) who planned to have children or planned to donate sperm/eggs throughout the trial period and for 3 months after the end of the study, or who did not wish to use one or more contraceptive methods during the trial period and 3 months after the end of the study; 21) Female participants with irregular menstruation, menstrual disorders (including menstrual cycle disorders, menstrual disorders, excessive menstrual volume); 22) Not tolerable on venipuncture, or a history of fainting on acupuncture and/or people with difficulty collecting blood ; 23) Special requiremen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anti-Xamax;AUEC0-t of anti-Xa;AUEC0-8 of anti-Xa;anti-IIamax;AUEC0-t of anti-IIa;AUEC0-8 of anti-IIa; | — |
Secondary
| Measure | Time frame |
|---|---|
| ?z of anti-Xa;t1/2 of anti-Xa;Tmax of anti-Xa;?z of anti-IIa;t1/2 of anti-IIa;Tmax of anti-IIa; | — |
Countries
China
Contacts
Public ContactJin Tao
Henan (Zhengzhou)Zhonghui Cardiovascular Hospital
Outcome results
None listed