Treatment of bleeding due to vitamin K deficiency and prevention of vitamin K deficiency that cannot be alleviated by nutritional therapy
Conditions
Interventions
fasting trial group 1:Test drug-reference drug
fasting trial group 2:Reference drug-test drug
fed trial group 1:Test drug-reference drug
fed trial group 2:Reference drug-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 subjects, both sexes, aged 18 years or older (including 18 years); 2. Weight for male =50.0 kg and weight for femal =45.0 kg with a body mass index (BMI) in the range of 19.0 ~ 26.0 kg/m2 [BMI = weight (kg)/height 2(m2)] (including threshold values); 3. The subjects and female partner are willing to have no childbearing 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 prior to screening and fully understand the content, procedure and possible adverse effects of the trial, and be able to complete the study in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Those who have developed or are developing a disease with abnormal clinical presentation to be excluded prior to screening, including but not limited to neurological/psychiatric, respiratory, cardiovascular, digestive (any history of gastrointestinal disorders affecting drug absorption), haematological and lymphatic, urological, endocrine, immune system disorders; 2. 12-lead electrocardiogram, vital signs examination, physical examination and clinical laboratory tests (routine blood, urinanalysis, blood biochemistry, coagulation tests), serological tests, blood pregnancy (female only), alcohol blood test, drug abuse screening, where the results show abnormalities with clinical significance; 3. Those who have undergone surgery within 3 months prior to screening or are scheduled to undergo surgery during the trial, and those who have undergone surgery that would affect the absorption, distribution, metabolism, or excretion of drugs; 4. History of clinical allergy to food, drugs, etc., especially known allergy to soy, peanut, vitamin K1 and any of its excipients; 5. Persons who have used any prescription, over-the-counter, herbal and vitamin medication within 2 weeks prior to screening; 6. Those who have consumed an average of >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) in the 3 months prior to screening, or who are unable to abstain from alcohol during the trial; 7.Those who have smoked an average of >5 cigarettes per day in the 3 months prior to screening, or who are unable to stop using any tobacco-based products during the trial; 8.Those who have donated blood including component blood or have lost a significant amount of blood (=400mL) within the 3 months prior to screening; 9. Those with a history of substance abuse within 6 months prior to screening; 10. Drug users within 3 months prior to screening; 11. Those who have a history of infectious disease (except for a history of novel coronavirus infection); 12. Those who have used any drugs that inhibits or induces hepatic metabolism of drugs within 28 days prior to screening (e.g. inducers - rifampicin, phenytoin, carbamazepine, omeprazole, phenobarbital, dexamethasone, neomycin, etc.; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines ); 13. Those who have used any medication that interacts with vitamin K1 within 4 weeks prior to screening (e.g. coumarin-based anticoagulants); 14. Enrolled in another clinical trial of a drug within 3 months prior to screening or not enrolled in this trial by themselves; 15. Those who have received vaccination within 1 month prior to screening (specifically: 1 month for neo-coronavirus vector vaccines and 2 weeks for inactivated and recombinant vaccines) or are scheduled to receive vaccination during the trial; 16. Those who have consumed excessive amounts of tea, coffee and/or caffeinated beverages (average of more than 8 cups, 1 cup ˜ 250 mL) on average per day during the 3 months prior to screening; 17. Persons who have special dietary requirements and are unable to accept a uniform diet; 18. Those who have difficulty in swallowing; 19. Persons with a previous history of thrombotic disease; 20. Those who have previously received vitamin K1 injection and have experienced irritation or allergic reactions; 21. Those who cannot tolerate venipuncture or have a h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic outcome (Plasma drug concentration); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safty outcome (Vital signs);Safty outcome (Physical examination);Safty outcome(12 lead Electrocardiogram);Safty outcome(blood routine test);Safty outcome(blood biochemistry test);Safty outcome(urinanalysis);Safty outcome(Coagulation test);Safty outcome(adverse event);Safty outcome(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