Pain
Conditions
Interventions
Group A:For subjects in Group A: In the first cycle, take 2 tablets of the 100 mg formulation under fasting conditions
In the second cycle, take 1 tablet of the 200 mg formulation under fasting conditions
In the third cycle, take 1 tablet of the 200 mg formulation under postprandial conditions.
Group B:For subjects in Group B: In the first cycle, take 1 tablet of the 200 mg formulation under fasting conditions
In the second cycle, take 1 tablet of the 200 mg formulation under postprandial conditions
In the third cycle, take 2 tablets of the 100 mg formulation under fasting conditions.
Group C:For subjects in Group C: In the first cycle, take 1 tablet of the 200 mg formulation under postprandial conditions
In the second cycle, take 2 tablets of the 100 mg formulation under fasting conditions
In the third cycle, take 1 tablet of the 200 mg formulation under fasting conditions.
Sponsors
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Provide informed consent prior to the initiation of any trial-related activities, have a full understanding of the purpose and significance of this trial, and be willing to comply with the trial protocol; 2.Aged between 18 and 55 years old (inclusive of the boundary values); 3.For male subjects, body weight >=50.0 kg; for female subjects, body weight>=45.0 kg. Body Mass Index (BMI) is calculated as weight (kg) / height^2(m^2), with a required range of 19.0 to 26.0 kg/m^2 (inclusive of the boundary values); 4.Able to tolerate a high-fat meal; 5.Have no unprotected sexual intercourse within two weeks prior to screening; have no childbearing plans from the start of screening until 3 months after the last administration of the trial drug; and be willing to voluntarily adopt effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Individuals who have previously or currently suffered from any clinically severe diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system\, urogenital system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that can interfere with the test results; 2. Have a history of allergies to drugs, food, or other substances; 3. Those who cannot tolerate venous puncture or have difficulty collecting blood from veins, or have a history of needle and blood fainting; 4. Those who have undergone surgery within 3 months before the trial or plan to undergo surgery during the study period; 5. Those who have taken any medication or health products (including Chinese herbal medicine) within 14 days before the experiment; 6. Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before the experiment (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 7. Those who have participated in any clinical trial and used any clinical trial drug within 3 months before the trial; 8. Those who donate blood or experience significant blood loss (>=200 mL, excluding menstrual bleeding in women), receive blood transfusions, or use blood products within the first 3 months of enrollment; 9. Pregnant or lactating women, as well as those who are unable to use one or more non pharmacological contraceptive methods during the trial period; 10. Those who have special dietary requirements and cannot follow a unified diet, or have difficulty swallowing; 11. Those who consume excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250 mL) every day; 12. Those who tested positive for nicotine before the first use of the study, or those who smoked more than 5 cigarettes per day in the three months prior to the trial, or those who were unable to stop using any tobacco products during the trial period; 13. Those who had a positive alcohol test result before the first medication use of the study, or those who frequently drank alcohol within the 6 months before the trial, that is, those who consumed more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol or 150mL of wine), or those who could not stop using any alcoholic products during the trial period; 14. Those who tested positive for drugs before the first use of the study, or had used soft drugs (such as marijuana) three months before the trial, or had taken hard drugs (such as cocaine, phencyclidine, etc.) one year before the trial; 15. Patients with abnormal vital signs (systolic blood pressure=140mmHg, diastolic blood pressure=90 mmHg; heart rate100 bpm) or abnormal physical examination, electrocardiogram, chest X-ray examination (AP), abdominal B-ultrasound examination, cardiac color ultrasound, laboratory examination have clinical significance (based on the judgment of the clinical research doctor); 16. Those who are screened positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and treponema pallidum antibody; 17. Having heart disease, including but not limited to congenital long QT syndrome, torsade de pointe, or risk factors for torsade de pointe (such as cardiac insuf
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dynamic 12-lead electrocardiogram;Vital Signs; | — |
Countries
China
Contacts
Public ContactYang Guoping
The Third Xiangya Hospital, Central South University
Outcome results
None listed