Pharmacokinetic study
Conditions
Interventions
RTRT:Delivery order: RTRT
TRTR:Delivery order: TRTR
Sponsors
Dongyang Hengdian Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese volunteers aged 18 years to 55 years old, both men and Non-pregnant non-lactation women. Volunteers over 55 years of age were not excluded during the trial; 2. Male subjects weighing no less than 50 kg, Female subjects weighing no less than 45 kg, body mass index (BMI) ranges from 19 to 28 kg/m2 (including cut-off values); 3. Subjects are healthy, with no history of heart, liver, kidney, digestive tract, nervous system, mental disorders, and metabolic diseases that have been judged by the investigator to have an impact on this study; 4. Sign the informed consent form before the trial and fully understand the test content, process, and possible adverse reactions. Subjects are able to communicate well with researchers.
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical trials within 90 days before the study, or plan to participate in other clinical trials during the study; 2. Subjects who had major surgery within 90 days before this trial, or plan to have surgery 3 months after the trial; 3. Blood donation or massive blood loss (>300 mL, excluding female physiological period), or received blood transfusion within 90 days before this trial; 4. Subjects with gastrointestinal diseases such as esophageal reflux, stomach bleeding or peptic ulcer disease, heartburn occurs more than once a week or any surgical procedure that may affect drug absorption (such as cholecystectomy) within 180 days; 5. People with a history of specific allergies (asthma, urticaria, eczema, etc.), or allergies (such as those who are allergic to two or more drugs, food, and pollen), or are known to be sensitive to the components of this medicine or the like); 6. Use any drugs within the 14 days before the test [including prescription drugs, over-the-counter drugs and/or alternative drugs (such as medicated diets, Chinese herbal medicines, hemostatic and blood-activating plants or health products) and the use of hormonal contraception or vaccines] or the researcher believes that it is not suitable to participate in the test; 7. Drug abuse history; 8. Positive result of urine screening test (tetrahydrocannabinolic acid, benzodiazepines, barbiturates, morphine, cocaine, methamphetamine); 9. Subjects who smoke more than 5 cigarettes per day 90 days before the study, subjects who drink frequently 28 days before the study, that is, drinking more than 7 units of alcohol(female)or 14 units of alcohol(males)per week (1 unit =150 mL of wine =360 mL of beer = 45 mL of alcohol); 10. Positive result of alcohol breathing test results; 11. Temperature (ear temperature) >=37.5?, obviously abnormal breathing according to the physician's judgment, systolic blood pressure>140mmHg or 90mmHg or 100 bpm; 12. Positive result of HIV-Ab, HBsAg, anti-HCV, TP test; 13. Subjects who have special requirements for diet, and cannot comply with a unified diet; 14. The subject refused to comply with the prohibition of beverages and foods (including tea, chocolate, coffee, cola, etc.) containing caffeine, alcohol, and grapefruit 48 hours before taking the drug; 15. Subjects with partners refuse to use effective contraception within 180 days from screening to completion of the study; 16. Female subjects have a positive result of pregnancy test; 17. Dizziness of needles, dizziness or difficulty in venous blood collection; 18. Subjects who have difficulty swallowing; 19. Obvious abnormalities in the physical examination and according to the physician's judgment; 20. Obvious abnormalities in the electrocardiogram according to the physician's judgment; 21. Obvious abnormalities in blood biochemistry, blood routine, and urine routine examinations according to the physician's judgment; 22. Subjects with other reasons cannot complete the research according to the physician's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactJIn Feiyan
Dongyang Hengdian Hospital
Outcome results
None listed