Equivalence study
Conditions
Interventions
two groups:Delivery order
Sponsors
Changsha Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Chinese volunteers aged 18 years and older (including 18 years old), both men and women; 2. Male subjects weigh not less than 50 kg, female subjects weigh less than 45 kg; body mass index ranges from 19 to 26 (including cut-off values). Body mass index (BMI) = weight (kg) / height 2 (m2); 3. Sign the informed consent form before the trial and fully understand the test content, process and possible adverse reactions; 4. Volunteers are able to communicate well with researchers and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: (1) (diagnosis period consultation + mesh screening) participated in any drug clinical trial within 3 months before the trial; (2) (screening period / check-in) There are cardiovascular system, endocrine system, nervous system, hematology, immunology (including genetic or immunodeficiency of individual or family history), psychiatry, metabolic abnormalities, lymphoproliferative diseases, a history of serious or opportunistic infections (including herpes, tuberculosis) and the investigators believe that there is still clinical significance; (3) (in the screening period) There are any nasal diseases that affect the absorption of the drug. a) history of long-term nasal congestion, runny nose, itchy nose, headache, nose bleeding and other symptoms; b) history of allergic diseases, asthma, aspirin stress, chronic respiratory diseases, skin allergies, etc.; c) history of nasal surgery, trauma History, allergic rhinitis, chronic rhinitis, history of sinusitis; (4) (in the screening period) those who have a history of allergies to budesonide or any of the ingredients in the prescription, who have a history of allergies to two or more foods or other substances; (5) (diagnosis during the screening period) can not tolerate venous sputum or have a history of halo, fainting; (6) (diagnosis during the screening period) within 6 months before the trial, the operator who has been judged by the investigator to affect the absorption, distribution, metabolism, and excretion of the drug; or surgery within 4 weeks before the trial; or planned to Surgery during the study; (7) (screening period / check-in) Those who have taken any drug within 14 days before the test (including Chinese herbal medicine); (8) (screening period / check-in consultation) Any drug that affects CYP3A4 enzyme activity (such as CYP3A4 inhibitor azole antifungal agent, macrolide drug, etc., CYP3A4 inducer such as Sheng John grass or some anticonvulsant, etc.); (9) (screening period consultation / check-in consultation) vaccination within 3 months before the use of the test drug; (10) (diagnosis during the screening period) blood donors or a large number of blood loss within 3 months before the test (>450ml, except for female physiological period); (11) (in the screening period) drug abusers or soft drugs (such as: marijuana) used 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) 1 year before the test; (12) (screening period / check-in) smokers or more than 5 cigarettes per day for the first 3 months of the trial, or can not stop using any tobacco products during the trial; (13) (screening period / check-in) Alcoholics or those who regularly drink alcohol within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360mL beer or 45mL alcohol with 40% alcohol or 150mL wine); or unwilling to stop drinking or any alcoholic products during the trial; (14) (screening period / check-in) Drink excessive tea, coffee and / or caffeinated beverages (8 cups or more, 1 cup = 250mL) per day, or do not agree to stop drinking tea, coffee and / during the test period Or a drink containing caffeine; (15) (during the hospitalization period) eating foods that may affect the metabolism of the drug within 7 days before taking the study drug (including grapefruit or grapefruit products, dragon fruit, mango, grapefruit, oranges, etc.), or the researcher believes that there are other Those who influence the absorption, distributio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactLi Xin
Changsha Third Hospital
Outcome results
None listed