None listed
Conditions
Interventions
Fasting group A:Test preparation followed by reference preparation
Fasting group B:Reference preparation followed by test preparation
Fed group A:Test preparation followed by reference preparation
Fed group B:Reference preparation followed by test preparation
Sponsors
Dongyang Hengdian Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy volunteers aged 18 to 55 years, both men and non-breastfeeding women; 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/m^2 (including cut-off values); 3. Subjects are healthy, 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 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. Subjects who have a history of specific allergies (such as sulfasalazine-containing drugs, salicylic acid and its derivatives, asthma, urticaria, eczema, etc.), or allergy to two or more kind of drugs, food and pollen, or allergy to any components of this preparation or similar ingredients; 6. Treatment of any medicine [the use of prescription drugs, over-the-counter drugs and/or alternative drugs (such as medicated diet, Chinese herbal medicine, hemostatic and blood-activating plants or health products) and hormone or vaccines] within 14 days before the study or the researcher believes that it is not suitable to participate in the trial; 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 on average in the 90 days before the test; 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. Difficulty in swallowing; 12. Subjects who control sodium (low-sodium or low-salt) diet; 13. Pulmonary dysfunction or severe liver function or renal dysfunction; 14. Temperature (ear temperature) >= 37.5 degree, obviously abnormal breathing according to the physician's judgment, systolic blood pressure > 140 mmHg or 90 mmHg or 100 bpm; 15. Positive result of HIV-Ab, HBsAg, HCVTP test; 16. Subjects who have special requirements for diet, and cannot comply with a unified diet; 17. Subjects who take beverages containing caffeine, alcohol or grapefruit (grapefruit juice) or foods (including tea, chocolate, coffee and cola) within 48 h before taking the study drug; 18. Subjects with partners refuse to use effective contraception within 180 days from screening to completion of the study; 19. Female subjects have positive result of pregnancy test; 20. Dizziness of needles, dizziness or difficulty in venous blood collection; 21. Obvious abnormalities in physical examination and according to the physician's judgment; 22. Obvious abnormalities in the electrocardiogram according to the physician's judgment; 23. Obvious abnormalities in blood biochemistry, blood routine, and urine routine examinations according to the physician's judgment; 24. Subjects with other reasons cannot complete the researchers according to the physician's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Concentration;AUC0-t (area under the concentration time curve from 0 to t);AUC0-8 (area under the concentration time curve from 0 to 8); | — |
Countries
China
Contacts
Public ContactChen Liping
Dongyang Hengdian Hospital
Outcome results
None listed