Bioequivalence study in healthy subjects
Conditions
Interventions
Feding Group A (T-R-T-R):The test preparation was taken orally in stage 1, the reference preparation was taken orally in stage 2, the test preparation was taken orally in stage 3, the reference prepar
Feding Group B (R-T-R-T):The reference preparation was taken orally in stage 1, the test preparation was taken orally in stage 2, the reference preparation was taken orally in stage 3, the test prep
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 51 Years
Inclusion criteria
Inclusion criteria: 1) Healthy subjects over 18 years old, both male and female; 2) weight =50.0kg with body mass index (BMI) in the range of 19.0 to 26.0kg/m2 (including 19.0 and 26.0kg/m2) (BMI= weight/height 2); 3) have no plans to have children for at least 6 months after the last study drug administration from 1 month before screening, voluntarily use effective contraceptive methods, and have no plans to donate sperm or eggs; 4) Subjects can communicate well with investigators, fully understand the purpose, nature, methods and possible adverse reactions of the trial, understand and comply with the requirements of this study, volunteer as subjects, and sign the informed consent approved by the ethics committee.
Exclusion criteria
Exclusion criteria: 1) Participants who had participated in any clinical trial within 3 months before screening, used a study drug, or did not participate in the clinical trial themselves; 2) patients with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, peptic ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within 3 years before screening and considered by the investigators to be clinically relevant; 3) have a history of chronic or serious diseases of the cardiovascular system (such as thromboembolism, hypertension), endocrine system (such as diabetes mellitus), urogenital system, mental nervous system (such as dizziness, syncope, cerebral hemorrhage), hematology (such as anemia or hemophilia), immune system (including genetic immunodeficiency of personal or family history), respiratory system, skeletal muscle, skin and recognized by the investigator Those still clinically relevant (inquiry); 4) patients with any disease that increases the risk of bleeding within 6 months before screening, such as intraocular bleeding, hemorrhoids, hematomas, hematochezia, hematemesis, hematuria, genital tract bleeding, vascular retinopathy, bronchiectasis, or pulmonary hemorrhage, or with any coagulopathy or a history of bleeding diseases; 5) patients with gingival bleeding or epistaxis within 14 days before screening that are still clinically relevant; 6) patients with a history of drug, food or other substance allergy, or a history of allergic diseases (e.g., anaphylactic shock, angioedema) that the investigator believes is still clinically relevant; 7) Those who cannot tolerate intravenous puncture or have a history of syncope or needle sickness; 8) those who underwent surgery within 6 months before screening that was judged by the researchers to affect the absorption, distribution, metabolism, and excretion of drugs; Or patients who had undergone surgery or biopsy within 3 months before screening or had major trauma and were judged by the investigator to be unsuitable for trial entry; If a surgical procedure was planned during the study or within 4 weeks of exit from the trial; 9) those who had taken any medicine (including Chinese herbal medicine) within 14 days before screening; 10) use of any CYP3A4 or P-gp inhibitor (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole, erythromycin, clarithromycin, dronedarone, HIV protease inhibitor (ritonavir), verapamil, diltiazem, amiodarone, cyclosporine, tacrolimus) within 30 days before screening; Or CYP3A4 or P-gp inducers (rifampicin, phenytoin, carbamazepine, phenobarbitone), or CYP3A4 or P-gp substrates (midazolam, digoxin, atorvastatin, omeprazole, quinidine); 11) use of any anticoagulant drugs within 30 days before screening, such as unfractionated heparin, low molecular weight heparin (enoxaparin, dalteparin), heparin derivatives (fondaparinux, desiludin), thrombolytic drugs, vitamin K antagonists, rivaroxaban, apixaban, Or antiplatelet drugs such as GP?b/?a receptor antagonists, ticlopidine, dipyridamole, prasugrel, ticagrelor, dextrose, sulfopyrazone, acetylsalicylic acid (ASA), clopidogrel, or fibrinolytic agents; 12) patients who had taken any antiepileptic drugs, nonsteroidal anti-inflammatory drugs (nsaids), serotonin reuptake inhibitors (SSRIs), or selective serotonin-norepinephrine reuptake inhibitors (SNRIs) within 30 days before screening; 13) who have received a vaccine within 2 weeks before screening or plan to receive one
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of rivaroxaban;Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| t1/2;Tmax; | — |
Countries
China
Contacts
Public ContactHu Yiting
Hebei General Hospital
Outcome results
None listed