Allergic disease
Conditions
Interventions
Group 1:Oral test preparation or reference preparation 10ml on an empty stomach
Group 2:Oral test preparation or reference preparation 10ml after meal
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, no gender limit; 2. The weight of male subjects is >= 50.0 kg, and the weight of female subjects is >=45.0 kg, and the body mass index (BMI) is between 19 - 26 kg/m^2; 3. Subjects voluntarily signed a written informed consent; 4. The subject can communicate well with the investigator and complete the trial in compliance with the research protocol.
Exclusion criteria
Exclusion criteria: 1. Those who have previously or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities or any other diseases that can interfere with the test results; 2. A history of allergies to drugs, food or other substances; 3. Those who have undergone surgery within 4 weeks before the trial, or who plan to undergo surgery during the study; 4. Those who have taken any medicines or health products (including Chinese herbal medicine) within 14 days before the test; 5. Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before the test (eg: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 6. Those who participated in any clinical trial and took any clinical trial drug within 3 months before the trial; 7. Those who have received live/attenuated vaccine within 4 weeks before screening or plan to receive live/attenuated vaccine during the trial; 8. Those who donated blood or lost a large amount of blood (>=200 mL, excluding menstrual blood loss in women), received blood transfusion or used blood products within 3 months before enrollment; 9. Pregnant and lactating patients, or those who cannot use one or more non-drug contraceptive measures during the trial; 10. Those who have special requirements for diet and cannot comply with the unified diet; 11. Those who drink too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL); 12. Smokers or those who smoked more than 5 cigarettes per day in the first 3 months of the trial and those who could not smoke during the hospitalization observation period of the trial; 13. Alcoholics or frequent drinkers within 6 months before the trial, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); 14. Drug abusers or those who have used soft drugs (such as marijuana) in the 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) in the 1 year before the test; 15. Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; pulse/heart rate 100 bpm) or abnormal physical examination, electrocardiogram and laboratory examination have clinical significance (subject to the judgment of the clinician); 16. Subjects may not be able to complete the study due to other reasons or should not be included in the investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
The Third Xiangya Hospital, Central South University
Outcome results
None listed