None
Conditions
Interventions
T-R group:First Period: Formulation T, Second Period: Formulation R
R-T group:First Period: Formulation R, Second Period: Formulation T
Sponsors
Zhejiang Xiaoshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntary participation in this trial, signing an informed consent form, the ability to communicate effectively with the researchers, and understanding and complying with all the requirements and restrictions of this trial. 2.Age 18 and above, both male and female. 3.Male body weight>=50.0 kg, female body weight >=45.0 kg; body mass index within 18.0~27.0 kg/m² (inclusive of boundary values).. 4.Within 3 months from the signing of the informed consent form until the last administration of the trial, if there is no pregnancy or plan to donate sperm or eggs, and during this period, relevant contraception regulations must be followed, and at least one efficient or acceptable non hormonal contraceptive method must be agreed upon, or if the male partner has undergone sterilization surgery at least 6 months before the screening visit.
Exclusion criteria
Exclusion criteria: 1.Individuals with a known history of allergies, or those who have allergic reactions, hypersensitivity reactions, intolerance, or contraindications to any component of the investigational drug. 2.Those who have had or currently have chronic or active gastrointestinal diseases, such as esophageal disease, gastroesophageal reflux, gastrointestinal perforation, gastrointestinal fistula, gastritis, gastrointestinal ulcer, malabsorption syndrome, inflammatory bowel disease, partial or complete intestinal obstruction, celiac disease, enteritis, pancreatitis, active gastrointestinal bleeding, or have undergone gastrointestinal surgeries such as gastric banding/gastrectomy, cholecystectomy, and intestinal resection (excluding appendectomy), and researchers believe that they still have clinical significance at present; Those who have digestive symptoms within 7 days before the administration of the investigational drug and are deemed unsuitable by the researcher to participate in this trial. 3.Individuals with a history of cardiovascular, cerebrovascular, peripheral vascular or thrombotic diseases or uncontrolled hypertension (systolic blood pressure>140 mmHg or diastolic blood pressure>90 mmHg at screening, confirmed by repeated testing).. 4.Individuals with any disease that increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, as well as those with active pathological bleeding or a history of intracranial hemorrhage. 5.Individuals with a history of malignant tumors within the past 5 years, excluding those cured of basal cell carcinoma or squamous cell carcinoma of the skin. 6.Other diseases with abnormal clinical manifestations that need to be excluded within 6 months before screening, including but not limited to circulatory system, endocrine system, nervous system, respiratory system, urinary system, hematology, immunology, psychiatry, metabolic and skeletal abnormalities, as well as chronic or active infectious diseases requiring systemic antibiotics, antifungal or antiviral treatment (including tuberculosis with latent treatment).. 7.Those who have undergone surgery within 3 months prior to administering the investigational drug, including surgeries that affect drug absorption, distribution, metabolism, and excretion, or those who plan to undergo surgery during the trial period. 8.Alcoholics, or those who frequently drink alcohol within 6 months before the administration of the investigational drug, that is, more than 14 units of alcohol [1 unit ˜ 360 mL beer or 45 mL Baijiu or 150 mL wine with 40% alcohol] every week, or those whose alcohol breath test results are greater than 0.0 mg/100mL before enrollment in this trial; Or refuse to stop drinking alcohol or consuming any alcoholic products throughout the entire trial period. 9.Individuals who abuse drugs, or have used soft drugs (such as marijuana) within the past 3 months before administering the experimental drug, or have used hard drugs (such as cocaine, phencyclidine, etc.) within the past 1 year before administering the experimental drug, or have tested positive for urinary drug screening before enrollment in this trial. 10.Smokers; Those who smoke more than 4 cigarettes per day within 3 months before administering the investigational drug, or those who cannot stop using any tobacco products (including electronic cigarettes) during the trial period. 11.Individuals who have consumed excessive amoun
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation; | — |
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic; | — |
Countries
China
Contacts
Public ContactChen Jinliang
Zhejiang Xiaoshan Hospital
Outcome results
None listed