None
Conditions
Interventions
A-B group:First Period: Formulation A, Second Period: Formulation B
B-A group:First Period: Formulation B, Second Period: Formulation A
Sponsors
Yiyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Informed Consent: Subjects must provide informed consent for the trial after being fully informed about the trial content, procedures, and potential adverse reactions. They must voluntarily sign a written informed consent form prior to participating in the study. 2. Communication and Compliance: Subjects must be able to communicate effectively with the investigators and comply with the protocol requirements throughout the trial. 3. Gender: Both males and females are eligible. 4. Age: Subjects must be 18 years of age or older (inclusive of the boundary value). 5. Weight: Male subjects must weigh >=50 kg; female subjects must weigh >=45 kg. The Body Mass Index (BMI = weight (kg) / height² (m²)) must be within the range of 19.0 to 26.0 kg/m² (inclusive of the boundary values). 6. Contraception Requirements: From the time of signing the informed consent form until 3 months after the last dose of the study medication, subjects must not plan to become pregnant or donate sperm/eggs. During this period, they must agree to use at least one highly effective or acceptable non-hormonal method of contraception
Exclusion criteria
Exclusion criteria: 1. Known Allergy History: Known history of allergy, hypersensitivity, intolerance, or contraindication to any component of the study medication. 2. Gastrointestinal Disease: Past or current chronic or active gastrointestinal disease (e.g., gastrointestinal perforation, fistula, esophageal disease, gastritis, peptic ulcers, colitis, gastroesophageal reflux, pancreatitis, active gastrointestinal bleeding, or previous gastrointestinal surgery) that the investigator considers clinically significant; or gastrointestinal symptoms within 7 days before dosing (diarrhea, constipation, nausea, vomiting, irregular bowel movements, or alternating diarrhea and constipation) that the investigator deems inappropriate for study participation. 3. Other Clinical Conditions: Presence of other clinically relevant diseases that need exclusion, including but not limited to cardiovascular, endocrine, neurological, respiratory, urinary, hematological, immunological, psychiatric, metabolic, or skeletal abnormalities, or any other condition or family history that could interfere with study outcomes (e.g., cirrhosis, tuberculosis, hypertension, diabetes [or family history], osteoporosis, glaucoma [or family history], cataracts, infections, chickenpox, liver dysfunction, renal impairment, visual disorders). 4. Increased Bleeding Risk: Any condition that increases bleeding risk, such as active ulcer with bleeding, clinically significant thrombocytopenia or anemia, active pathological bleeding, or history of intracranial hemorrhage. 5. Recent Surgery: Surgery within 3 months prior to screening, including surgeries affecting drug absorption, distribution, metabolism, or excretion, or planned surgery during the study period. 6. Inability to Tolerate Venipuncture: Inability to tolerate venipuncture or history of fainting due to blood or needle exposure. 7. Alcohol Abuse: History of alcoholism or regular alcohol consumption exceeding 14 units per week (1 unit ~ 360 mL beer, 45 mL 40% alcohol by volume spirits, or 150 mL wine) within 6 months before dosing. 8. Drug Abuse: History of substance abuse, including use of soft drugs (e.g., marijuana) within 3 months before dosing or hard drugs (e.g., cocaine, phencyclidine) within 1 year before dosing. 9. Smoking Habit: Smokers who have smoked more than 5 cigarettes daily within 3 months before dosing or cannot stop using tobacco products during the study. 10. Excessive Caffeine Consumption: Consumption of excessive tea, coffee, or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) within 3 months before dosing. 11. Special Dietary Requirements: Special dietary requirements that prevent adherence to a standardized diet or difficulty swallowing. 12. Carbohydrate Intolerance: Lactose, galactose, or fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency, or complete lactase deficiency (history of diarrhea after drinking milk). 13. Physical Examination Abnormalities: Abnormal findings in physical examination, vital signs, 12-lead ECG, or laboratory tests deemed clinically significant by a physician. 14. Infectious Diseases: Positive test results for hepatitis B surface antigen, hepatitis C antibodies, HIV antibodies, or syphilis antibodies. 15. Vaccination: Vaccination within 1 month before dosing or planned vaccination during the study period. 16. Liver Enzyme Modulators: Use of medications that inhibit or induce hepatic drug-metabolizing enzymes within 1 month before dosing (e.g., inducers-bar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic;Safety evaluation; | — |
Countries
China
Contacts
Public ContactLi Wei
Yiyang Central Hospital
Outcome results
None listed