vitamin K deficiency
Conditions
Interventions
Group A (TRT):1mL of intravenous administration of drug T in the first cycle
In the second cycle, 1mL of drug R was administered intravenously
In the third cycle, 1mL of drug T was administered intramuscularly with a washout period of 9 days
Group B (RTT):1mL of drug R intravenously in the first cycle
In the second cycle, 1mL of drug T was administered intravenously
Sponsors
Beijing Shijitan Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Gender: male and female healthy subjects, and the selected male and female subjects should have an appropriate gender ratio; 2. Age: healthy subjects aged 18 years and above (including 18 years old); 3. Weight: male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and the body mass index [BMI= weight (kg)/ height 2(m2)] is in the range of 19.0~26.0 kg/m2 (inclusive); 4.Subjects gave informed consent to this study before the experiment, and voluntarily signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Allergic to any component in vitamin K1 injection and its related compounds and accessories, or allergic to two or more drugs (or foods); 2.Those who can't follow the unified diet (such as intolerance to standard meals); 3.Those who can't tolerate venipuncture or intramuscular injection, and those who have a history of fainting; 4.There is a major medical history of cardiovascular, liver, kidney, endocrine, digestive tract, blood system, respiratory system, malignant tumor, mental disorder, etc., which is judged by the researcher to be clinically significant, or there are the above diseases; 5.Screening patients who have undergone major surgery within 6 months before, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect the absorption, distribution, metabolism and excretion of drugs (except appendicitis surgery); 6.Those who have used long-acting estrogen or progesterone injections or implanted tablets within 6 months before screening; Those who have used short-acting contraceptives within 4 weeks before screening; 7.Have used any drugs (such as coumarin anticoagulants) that interact with vitamin K1 within 4 weeks before screening; 8.Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products within 14 days before screening; 9.Those who have a history of drug abuse (such as morphine, ketamine, tetrahydrocannabinol, methamphetamine, methylene dioxygen, cocaine, etc.) within one year before screening; 10.Drinking more than 14 standard units per week within 6 months before screening (1 standard unit contains 14g alcohol, such as 360ml beer or 45ml spirits with 40% alcohol content or 150ml wine); 11.Those who smoked more than 5 cigarettes a day in the first 3 months of screening, or those who could not accept smoking ban from the time of selection to the whole trial period; 12.Those who have drunk too much (more than 8 cups a day, 1 cup =200ml) tea, coffee and other beverages containing xanthine for a long time (within 3 months before screening); 13.Those who participated in other clinical trials within 3 months before the first medication and used experimental drugs or experimental instruments; 14.Those who donated blood or lost blood >=400ml within 3 months before the first medication, or planned to donate blood or blood components within 3 months during or after the study; 15.Known pregnant or lactating women, as well as male subjects (or their partners) or female subjects with pregnancy plans during the whole trial period and within 3 months after the end of the study; 16.Female subjects who had unprotected sex within 14 days before screening; 17.Those who have been vaccinated within 14 days before screening; 18.Physical examination, vital sign measurement, electrocardiogram examination, chest imaging examination, blood routine examination, urine routine examination, blood biochemistry and blood coagulation function during the screening period, and the abnormality judged by the researcher has clinical significance; 19.Abnormal results of hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody or human immunodeficiency virus antibody during the screening period have clinical significance; 20.Screening female subjects whose blood pregnancy results are positive or exceed the upper limit of the normal range; 21.Study the positive urine screening of drug abuse before the first medication; 22.Study the positiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration (Cmax) of E isomer of vitamin K1;Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0–t) of E isomer of vitamin K1;Area under the concentration-time curve from time 0 to 8 (AUC0–8) of E isomer of vitamin K1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak time(Tmax) of E and Z isomer of vitamin K1;Elimination half-life (t1/2z) of E and Z isomer of vitamin K1;Apparent distribution volume(Vz/F) of E and Z isomer of vitamin K1;Apparent clearance rate(CLz/F) of E and Z isomer of vitamin K1;Elimination rate constant(?z) of E and Z isomer of vitamin K1;Extrapolation area percentage(AUC_%Extrap) of E and Z isomer of vitamin K1;Peak concentration (Cmax) of Z isomer of vitamin K1;Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0–t) of Z isomer of vitamin K1;Area under the concentration-time curve from time 0 to 8 (AUC0–8) of Z isomer of vitamin K1;Area under the effect-time curve from time 0 to the last time point ; | — |
Countries
China
Contacts
Public ContactWang Xinghe
Beijing Shijitan Hospital affiliated to Capital Medical University
Outcome results
None listed