None listed
Conditions
Interventions
Sequence 1 (RT group):In the fasting state, the reference preparation was orally administered in the first cycle, and the test preparation was orally administered in the second cycle, with a washout p
Sequence 2 (TR group):In the fasting state, the test preparation was orally administered in the first cycle, and the reference preparation was orally administered in the second cycle
Sequence 3 (RT group):The reference preparation was orally administered in the first cycle and the test preparation was orally administered in the second cycle after meals, with a washout period of 7
Sequence 4 (T-R group):In fed state, the test preparation was taken orally in the first period and the reference preparation was taken orally in the second period, with a washout period of 7 days
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged above 18 years (including 18 years old), no gender limit; 2. Body mass index (BMI) = weight (kg)/height^2 (m^2), BMI in the range of 19.0-26.0 (including the critical value), and the weight of men is not less than 50.0 kg, and the weight of women is not less than 45.0 kg; 3. The subjects (including male subjects) have no pregnancy plan in the next 6 months and voluntarily take effective contraceptive measures; 4. Before the trial, fully understand the trial content, process and possible adverse reactions, and sign the informed consent form, voluntarily participate in the trial, and be able to complete the study according to the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. HBs Ag, HCV antibody, HIV antibody, Treponema pallidum antibody positive; 2. Patients with abnormal general physical examination, blood biochemistry, blood and urine routine and ECG examination with clinical significance; 3. Patients with clear history of heart, respiratory, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, malignant tumor, blood, skeletal system, nervous system disease or psychiatric/functional disorder in the past or present clinically ; 4. Lactose intolerance, galactosemia or glucose/galactose malabsorption; 5. Those who have a history of drug or food allergy, or are known to be allergic to the ingredients of this drug; 6. Those who have taken any medicines, including over-the-counter medicines and Chinese herbal medicines, within 2 weeks before screening; 7. Use of any drug that inhibits or induces liver drug metabolizing enzymes within 30 days prior to screening (eg: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, selective 5-HT reuptake inhibitor antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 8. The average weekly alcohol consumption in the 3 months prior to screening is greater than 14 units of alcohol (1 unit = 285 mL of beer, or 25 mL of spirits, or 150 mL of wine) or a positive alcohol breath test; 9. Those who smoked more than 5 cigarettes per day on average within 1 month before screening; 10. Drug abuse or drug dependence, or positive drug screening; 11. Those who have donated blood or lost a large amount of blood (> 400 mL) within 3 months before screening or participated in drug trials as patients; 12. Taking special diets (including grapefruit, and/or xanthine-containing diets, etc.) within 48 hours before administration, or other beverages or foods that affect drug absorption, distribution, metabolism, excretion, etc.; 13. Those who drink excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day within 1 month before screening; 14. Those who have special requirements for diet cannot comply with the provided diet and corresponding regulations; 15. Female patients are breastfeeding or have a positive pregnancy result during the screening period or the test; 16. The investigator judges that the patient has other factors that make it inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| area under the plasma concentration time curve;peak concentration; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital
Outcome results
None listed