Moderate to severe seasonal allergic rhinitis symptoms
Conditions
Interventions
Group TR:In the first period, 200ug of the test preparation was accepted, and the cleaning period was 7 days. In the second period, 200ug of the reference preparation was accepted
Reference Group:In the first period, 200ug of reference preparation was accepted, and the cleaning period was 7 days. In the second period, 200ug of test preparation was accepted
Sponsors
Shulan(Hangzhou) Hosipital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1 Sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the test; 2. Be able to complete the study in accordance with the requirements of the test protocol; 3 Participants (including partners) had no pregnancy plan and voluntarily adopted effective contraception from 2 weeks before administration to 6 months after the last study drug administration, as shown in Appendix 1 for specific contraceptive measures; 4 Male and female subjects aged 18~65 years (including cut-off values); 5 Male subjects weighed at least 50 kg and female subjects weighed at least 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index in the range of 18.0~28.0 kg/m2 (including critical value); 6 Physical examination and vital signs are normal or abnormal and have no clinical significance.
Exclusion criteria
Exclusion criteria: 1 Smokers/non-quitters screened in the previous 6 months; or the use of any tobacco-based product cannot be stopped during the test, or the nicotine screening result is positive; 2 Those who have a history of allergy to this product or other glucocorticoids, allergic constitution (two or more drugs, food and environmental allergies, especially soy, alcohol, eggs); 3 Regular drinkers in the 6 months prior to screening, i.e. those who drank more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits or 150 mL of wine with 40% alcohol), or who were not guaranteed to give up drinking during the trial period; 4 Those who donated blood or lost a large amount of blood (> 400 mL) within 3 months before screening; 5 Those who have undergone surgery within 3 months prior to screening or plan to undergo surgery during the trial, and those who have undergone surgery that will affect drug absorption, distribution, metabolism and excretion (except appendicitis/skin surgery); 6 People with a history of active or stationary tuberculosis; 7 People with acute upper respiratory tract infection; 8 Those who took any drugs that affect CYP3A4 enzymes (such as ketoconazole, itraconazole, clarithromycin, ritonavir, products containing cobistita, etc.) 1 month before screening, see Appendix 6 for details; 9 Those who have taken any prescription drug, over-the-counter drug, any vitamin product or herbal medicine, or have been vaccinated within 14 days prior to screening; 10 Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day for the 3 months prior to screening; 11. Those who have special dietary requirements, cannot accept a unified diet, or have recently had significant changes in diet or exercise habits; 12. Those who have taken investigational drugs, used glucocorticoids or participated in drug clinical trials within 3 months prior to administration; 13 Abnormal external nasal examination or oropharyngeal examination at the time of screening with clinical significance; 14 Those with cataracts, glaucoma, conjunctivitis or other eye infections; 15 Those with poor vein condition, or difficulty in blood collection due to tattoos, or inability to tolerate venipuncture; 16 After electrocardiogram, chest X-ray/CT examination, the investigator judged that the abnormality was clinically significant; 17. Female subjects were breastfeeding or had a positive serum pregnancy result during the screening period or during the trial; 18 Clinical laboratory tests have abnormal clinical significance, or other clinical findings show clinically significant diseases of the following diseases, including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immunological, respiratory system (a. history with long-term nasal congestion, runny nose, headache, nosebleeds and other symptoms; b. Asthma, chronic respiratory diseases, etc.; c. History of allergic rhinitis, chronic rhinitis, sinusitis), psychiatric or cardiovascular and cerebrovascular diseases; 19 Positive screening for viral hepatitis (including hepatitis B and C), AIDS antibody, and treponemal antibody; 20 Acute illness from the screening stage to the study administration; 21 Those who have consumed dragon fruit, mango, grapefruit, lime, star fruit or food or beverages prepared by them within 48 hours before administration; 22 Those who ingest chocolate, any caffeinated o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;?z;AUC_%Extrap; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2z; | — |
Countries
China
Contacts
Public ContactChen Guilin
Shulan (Hangzhou) Hospital
Outcome results
None listed