Venous thromboembolism (VTE)
Conditions
Interventions
T-R Group:Participants underwent a two-cycle trial, administered 1 time per cycle in the fasting state, administering the test formulation (T)-reference formulation (R) in sequence order. There is a 7
R-T group:Participants undergo two cycles of trial, administered 1 fasting state per cycle, administering the reference formulation (R)-test formulation (T) in sequence. There is a 7-day washout perio
Sponsors
Hopeshine-Minsheng Hospital of Xinzheng
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Able to sign Informed Consent Form before the trial, and fully understand the trial content, process and possible adverse drug reactions (ADRs); 2.Able to complete the trial in compliance with the protocol; 3.Participants (including males) willing to adopt effective contraceptive methods and with no pregnancy plan from 14 days before screening to 3 months after discharge from the site in period 2; 4.Males and females between 18 and 55 years old, inclusive; 5.At least 50 kg for males, 45 kg for females, with a Body Mass Index (BMI) = Weight/Height2 (kg/m^2) between 19.0-26.0 kg/m^2, inclusive; 6.No history of chronic or serious cardiac, hepatic, renal, digestive tract, nervous system, mental and metabolic disorders, etc. Only those who meet all the criteria listed above can be enrolled.
Exclusion criteria
Exclusion criteria: 1.With >= 5 cigarettes per day on average within 3 months before screening, or not able to quit smoking during the trial; 2.Allergic to two or more substances, or specific allergy history (e.g. asthma, allergic rhinitis, urticaria, eczema), or allergic to the components of investigational products and its analogues; 3.A history of alcohol abuse (alcohol consumption of more than 14 units per week: 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine), or consumption of any products containing alcohol within 24 h prior to receiving investigational product, or a positive result of the alcohol breath test; 4.Blood donation or massive blood loss (> 400 mL, except for menstrual blood of female participants) within 3 months prior to receiving investigational product; Or any blood donation plan from screening until 1 month after the last administration; 5.A history of dysphagia, or any gastrointestinal disease which may affect the drug absorption; 6.Histories of active bleeding, coagulopathy, or other diseases that increase the risk of bleeding; 7.Participants with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; 8.Creatinine clearance rate < 80 mL/min; 9.Use of any CYP3A4/5 and P-gp inhibitor or inducer drugs (e.g., ketoconazole, itraconazole, ritonavir, rifampicin, carbamazepine, phenytoin, St. John's Wort, etc.) within 28 days prior to receiving investigational product; 10.Use of any prescription drugs within 14 days prior to receiving investigational product; 11.Use of any over-the-counter (OTC) drugs, herbal medicine or health supplementary within 7 days prior to receiving investigational product; 12.Consumption of any special diets (such as grapefruit), or strenuous exercise engagement, or other factors affecting drug absorption, distribution, metabolism and excretion within 7 days prior to receiving investigational product; 13.Participation in other drug clinical trials within 3 months prior to receiving investigational product; 14.Any clinically significant abnormality findings, as judged by a clinical physican, including physical examination, vital signs, electrocardiogram and laboratory tests (including biochemistry, hematology, urinalysis, coagulation function, serum pregnancy test (only for females) and viral tests); 15.Consumption of chocolate or any food/beverage containing caffeine or rich in xanthine within 48 h prior to receiving investigational product; 16.A positive result of the drug abuse test, or a history of drug abuse in the past 5 years, or intake of any narcotic drugs within 3 months prior to the trial; 17.A positive result of the pregnancy test, or in lactation during screening or the test period for female participants; 18.Not tolerable on venipuncture, or a history of fainting on acupuncture and/or blood; 19.Special requirements and unable to follow the unified diet; 20.Unable to participate in this trial for participants’ own reasons; 21.Other conditions in which participants are not suitable for the trial determined by investigators. Those who meet any of the criteria listed above must not be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary PK parameters: Cmax;The primary PK parameters: AUC0-t;The primary PK parameters: AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary PK parameters: Tmax;The secondary PK parameters: Kel;The secondary PK parameters: t1/2;The secondary PK parameters: AUC_%Extrap;The secondary PK parameters: MRT0-8;The secondary PK parameters: CL/F;The secondary PK parameters: Vz/F;The secondary PK parameters: Frel; | — |
Countries
China
Contacts
Public ContactJinxi Chen
Hopeshine-Minsheng Hospital of Xinzheng
Outcome results
None listed