Treatment of bleeding due to vitamin K deficiency and prevention of vitamin K deficiency that cannot be alleviated by nutritional therapy
Conditions
Interventions
injection administration 1:Intravenous Test drug - Intravenous Reference drug - Intramuscular Test drug - Intramuscular Reference drug
injection administration 2:Intravenous Reference drug - Intravenous Test drug - Intramuscular Reference drug - Intramuscular Test drug
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese adult male and female volunteers aged 18 years or older (including 18 years). 2. Weight = 50 kg for male; weight = 40 kg for female; with a body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including borderline values; BMI = weight kg/height2 m2). 3. Subject and his female partner are willing to have no reproductive plans and voluntarily use effective contraception and have no plans to donate sperm or eggs from 2 weeks prior to screening until 6 months after the last dose of the study drug, and to ensure the use of one or more non-pharmacological contraceptive measures during sexual intercourse from 2 weeks prior to screening until 1 month after the last dose of the study drug. 4. Sign an informed consent form before screening and fully understand the content, process and possible adverse effects of the trial, and be able to complete the study in accordance with the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Those who have developed or developing diseases with abnormal clinical manifestations to be excluded prior to screening, including but not limited to neurological/psychiatric, respiratory, cardiovascular, digestive (any history of gastrointestinal disorders affecting drug absorption), hematologic and lymphatic, urinary, endocrine, and immune system disorders. 2.Any abnormalities with clinical significance of 12-lead electrocardiogram, vital signs examination, physical examination and clinical laboratory tests (routine blood, urine, blood biochemistry, coagulation tests), serological tests, blood pregnancy (female only), alcohol blood test, urine drug screening. 3. Those who have undergone surgery within 3 months prior to screening or are scheduled to undergo surgery during the study period, and those who have undergone surgery that would affect drug absorption, distribution, metabolism, or excretion. 4. clinical history of food and drug allergy, especially known allergy to soy, peanut, vitamin K1 and any component of its excipients. 5. Those who have used any prescription drugs, over-the-counter drugs, herbal medicines and vitamins within 2 weeks prior to screening. 6. Those who consumed an average of more than 14 units of alcohol per week (1 unit of alcohol ˜ 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine) during the 3 months prior to screening, or who were unable to abstain from alcohol during the trial period. 7. Those who smoked more than 5 cigarettes per day on average during the 3 months prior to screening, or who were unable to stop using any tobacco-based products during the trial period. 8. Those who donated blood including blood component or lost a significant amount of blood (=400mL) within 3 months prior to screening. 9. Those with a history of substance abuse within 6 months prior to screening. 10. Those who have used drugs within 3 months prior to screening. 11. Those with a history of infectious disease (except for a history of covid-19 infection). 12. Those have used any medicine that inhibit or induce hepatic metabolism (e.g., inducers - rifampicin, phenytoin, carbamazepine, omeprazole, phenobarbital, dexamethasone, neomycin, etc.; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within 28 days prior to screening. 13. Those who have used any drugs that interacts with vitamin K1 within 4 weeks prior to screening (e.g. coumarin-based anticoagulants). 14. Those who have enrolled in another clinical trial within 3 months prior to screening or non-self participate in this clinical trial. 15. Those who have received vaccination within 1 month prior to screening (special: 1 month for covid-19 vector vaccine, 2 weeks for inactivated and recombinant vaccines) or those who plan to receive vaccination during the trial. 16. Those who have consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups on average, 1 cup ˜ 250 mL) on average per day during the 3 months prior to screening 17. Those with special dietary requirements and cannot accept a uniform diet. 18. Those who have difficulty swallowing. 19. Those with a previous history of thrombotic disease. 20. Those who have been treated with vitamin K1 injection and have experienced irritation or allergic reactions. 21. Those who cannot tolerate venipuncture or have a history of needle sicknes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;Physical examination;12 lead Electrocardiogram;blood routine test;blood biochemistry test;urine routine test;Coagulation test;adverse event;Combination of medications; | — |
Countries
China
Contacts
Public ContactWei hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed