None listed
Conditions
Interventions
(Fed) T-R:In fed study, subjects took the test preparation in the first cycle, and took the reference preparation in the second cycle
(Fed) R-T:In fed study, subjects took the reference preparation in the first cycle, and took the test preparation in the second cycle
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 51 Years
Inclusion criteria
Inclusion criteria: 1. The subject fully understands the purpose, nature, method and possible adverse reactions of the trial, voluntarily acts as a subject, and signs the informed consent form before the start of any research procedure; 2. Healthy male and female subjects aged 18 years or older (including 18 years of age) with appropriate sex ratios; 3. Male weight = 50.0 kg, female weight = 45.0 kg, body mass index (BMI) in the range of 19.0~28.0 kg/m2 (including critical value); 4. The subject has no history of cardiovascular, digestive, respiratory, genitourinary disease, blood and lymph, endocrine, immunological, psychiatric, neurological chronic disease or serious disease (consultation); 5. Vital signs examination, physical examination, laboratory tests (blood analysis, urinalysis Urine sediment quantification, blood biochemistry, eight preoperative items, four blood coagulation, blood pregnancy test (women)), 12-lead electrocardiogram, chest X-ray examination and alcohol breath test, urine drug screening, the results show no abnormality or abnormal and no clinical significance; 6. The subject can communicate well with the investigator, and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Persons who have a history of drug or food allergies or allergies; 2. Persons who have a history of dysphagia or any gastrointestinal disease that affects the absorption of drugs; 3. Any history of surgery, trauma that may affect the safety of the test or the metabolic process of the drug, or those who have a history of surgery within 3 months before screening or plan to undergo surgery during the study; 4. Persons who have used any drugs or health products within 2 weeks before screening; 5. Persons with a history of drug abuse within 6 months prior to screening; 6. Persons who have used drugs within 3 months before screening; 7. Persons who smoked more than 5 cigarettes per day within 3 months before screening, or could not stop using any tobacco products during the test period; 8.Persons who drank more than 14 units per week (1 unit = 357 mL of beer with 5% alcohol or 43 mL of liquor with 40% alcohol or 147 mL of wine with 12% alcohol content in the 3 months before screening), or who could not abstain from alcohol during the trial; 9. Those who drank excessive tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 ml) per day within 3 months before screening; 10. Those who have participated in other drug clinical trials within 3 months before screening or who have not participated in clinical trials in person; 11. Those who donate blood within 3 months before screening, including component blood or large blood loss (= 400mL), receive blood transfusion or use blood products; 12. Subject (female) is pregnant or lactating; 13. Those who cannot tolerate venipuncture or difficulty in blood collection, and those who have a history of needle sickness; 14. Lactose intolerance (those who have had diarrhea from drinking milk); 15. Those who have special requirements for diet and cannot accept a unified diet; 16. Those who have a family plan from 1 month before screening to 6 months after the last administration of the study drug, and are unwilling or unable to take effective contraceptive measures; 17. Use of any drugs that inhibit or induce liver metabolism of drugs within 28 days prior to screening (inducers: rifampicin, carbamazepine, phenytoin; Inhibitors: bupropion, quinidine, fluoxetine, paroxetine, ketoconazole); 18. Those with previous suicidal/depressive tendencies, a history of depression, a history of seizures, a history of mania or hypomania, a history of glaucoma, a history of hypersensitivity reactions (such as immediate allergic reactions, angioedema), a history of skin allergies, and a history of abnormal bleeding (such as gastrointestinal bleeding, abnormal skin congestion); 19. Hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or syphilis treponemal antibody test has one or more abnormalities of clinical significance; 20. Alcohol breath test results greater than 0.0mg/100mL or positive urine drug screening (morphine, methamphetamine, ketamine); 21. Those who have acute diseases before using clinical trial drugs; 22. Subjects judged by other investigators to be unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-72h;t1/2; | — |
Countries
China
Contacts
Public ContactMa Jie
Hebei General Hospital
Outcome results
None listed