Bioavailability study in healthy subject
Conditions
Interventions
Fasting Group A:In stage 1, take 1 tablet of the test preparation on an empty stomach, and in stage 2, take 1 tablet of the reference preparation
Fasting GroupB:In stage 1, one tablet of the reference preparation was taken orally on an empty stomach, and in stage 2, one tablet of the test preparation was taken
Feding Group A:In stage 1, take 1 tablet of test preparation orally after meals
in stage 2, take 1 tablet of reference preparation.
Feding Group B:IIn stage 1, one tablet of the reference preparation was taken orally after meals, and in stage 2, one tablet of the test preparation was taken.
Sponsors
Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Those who understand the content of the informed consent form, voluntarily participate and sign the informed consent form; 2. Healthy male or female with appropriate sex ratio; 3. Age 18 and above; 4. Female weight >= 45.0kg, male weight >= 50.0kg, body mass index (BMI) = weight (kg)/height 2 (m^2), and the body mass index is 19-26kg/m^2, including the critical value.
Exclusion criteria
Exclusion criteria: 1. Abnormalities in general physical examination, blood routine, blood biochemistry, urine routine, 12-lead electrocardiogram, virological examination, coagulation function examination and other abnormalities with clinical significance; 2. Those who have a history of serious heart, lung, liver, kidney, blood, gastrointestinal, endocrine, immune, skin disease, nervous or mental diseases, or existing diseases mentioned above, who are judged by the investigators to be unsuitable for participating in this research; 3. Those with coagulation dysfunction, or those with major trauma and bleeding history (intracranial hemorrhage, gastrointestinal bleeding, purpura, or active pathological bleeding) or those with bleeding tendency (such as frequent relapse) within 3 months before screening bleeding gums); 4. Those who have undergone major surgery within 6 months before screening, or plan to have surgery during the study period; 5. People with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (for example: people with diarrhea after drinking milk); 6. Those whose CrCl value is =50mL/min is proved by the inspection during the screening period; 7. Hepatitis B surface antigen and/or hepatitis B e antigen positive, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody test has one or more clinical significance; 8. Those who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products) within 14 days before screening; 9. Those who have a history of drug abuse or have a positive drug screening test in the past 5 years; 10. Those who have a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (such as those who are allergic to two or more drugs, foods such as milk and pollen), or those who are known to be allergic to the components of this drug or analogues ; 11. Difficulty in blood collection or fainting of needles or blood; 12. Those who have a positive alcohol breath test result; 13. Alcohol abuse within 3 months before screening (over 14 units of alcohol per week: 1 unit = about 285 mL of beer, or about 25 mL of spirits, or about 100 mL of wine) or those who do not agree to quit drinking during the test; 14. Those who drank excessive tea, coffee, or caffeinated beverages within 3 months before screening (more than 8 cups a day, 1 cup = 250mL), or consumed any caffeine or caffeinated beverages within 48 hours before the first administration of the study Food or beverages with grapefruit juice (such as coffee, strong tea, chocolate, cola, grapefruit, etc.); 15. Those who cannot comply with a unified diet (such as intolerance to standard meals, etc.) or who have difficulty swallowing; 16. Those who smoked more than 5 cigarettes per day within 3 months before screening or those who did not agree to quit smoking during the trial; 17. Those who have participated in other clinical trials within 3 months before screening; 18. Blood donation or other causes of bleeding within 3 months before screening, resulting in a total blood loss >= 400mL (except for female physiological blood loss); 19. Pregnant or breastfeeding women (within one year after giving birth or without stopping breastfeeding) and male subjects (or their partners) or female subjects have pregnancy plans throughout the test period and within 3 months after the end of the test, and no Those who are wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apixaban concentration in plasma;Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| t1/2;Tmax;?z;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactBin Wei
Outcome results
None listed