| Eligibility |
Inclusion Criteria:
1) the subjects were fully aware of the purpose, nature, methods and possible adverse
reactions of the trial, voluntarily act as subjects, and sign an informed consent form
before the commencement of any research process.
2)Healthy volunteers between the ages of 18 to 50 years old (inclusive). 3)Weight: male =
50.0kg, female = 45.0kg; Body Mass Index (BMI) =19 and = 24 kg/m2.
4) The physical examination, vital sign measurements, clinical laboratory assessments
hematology, clinical chemistry, or urinalysis, etc.) and 12-lead ECG were judged normal, or
abnormal without clinical significance by the investigators.
Exclusion Criteria:
1. Positive test results for HIV, syphilis antibody, hepatitis B surface antigen (HBsAg),
or hepatitis C antibody (HCV Ab) at Screening.
2) Dysphagia or documented history of any gastrointestinal disorders that affect drug
absorption.
3) Subjects with difficulty in venipuncture, those who cannot tolerate venipuncture, and
those who have a history of needlesickness and bloodsickness.
4) Positive tests for urine drugs of abuse at Screening or a history of drug or alcohol
abuse/dependence.
5) Use of tobacco products 3 months before screening. 6)Heavy tea, coffee and / or
caffeinated drinks (more than 8 cups, 1 cup = 250 mL) drinker per day within 3 months prior
to screening.
7)Subjects who drunk frequently within 6 months prior to screening (intake of more than 14
units of alcohol per week. A unit is 360 mL beer, 45 mL of 40% liquor or 150 mL wine).
8)Any out-of-normal-range PT, aPTT, TT, FIB,INR, protein C, protein S or coagulation
factors II, VII, X at screening.
9)History of cardiovascular, renal, pulmonary, nervous system, liver and/or endocrine
disease.
10)Documented history of bleeding diathesis, coagulopathy, or inherited disorders of
coagulation.
11)Evidence of active bleeding, including but not limited to gastrointestinal bleeding
(hematemesis, hematochezia, positive fecal occult blood), urinary tract bleeding, mucosal
bleeding (gingival, epistaxis) and unexplained subcutaneous bleeding or ecchymosis.
12)Participation in a previous clinical trial within 3 months prior to Screening.
13)Clinically significant surgical procedure within 4 weeks prior to Screening or planned
to undergo surgery during the study period.
14) Clinically significant blood loss or blood donation > 550 ml within 3 months prior to
Screening.
15)Taking any medication 14 days prior to Screening. 16)Known allergy or hypersensitivity
to warfarin or the investigational product.
17)Pregnancy or Lactation. 18)Female subjects cannot avoid menstruation during
administration. 19)subjects of childbearing age are not guaranteed to have no fertility
plan, sperm donation, egg donation plan and voluntary use of non-drug contraceptive
measures (including subcutaneous injection of contraceptive, contraceptive injections,
subcutaneous implantation of contraceptives, local contraceptives such as spermicide, etc.)
from two weeks before screening to 6 months after the end of the trial.
20)Investigator would make the subject unsuitable for the study or put them at additional
risks.
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