Acute asthma exacerbation in children and adolescents aged 4-16 years
Conditions
Interventions
Group B:The first cycle of reference preparation (original GlaxoSmithKline Australia Pty Ltd. production of fluticasone propionate nebulized inhalation suspension (2ml: 0.5mg))
The second cycle of test preparation (fluticasone propionate nebulized inhalation suspension (2ml: 0.5mg) produced by Sichuan Prite Pharmaceutical Co., Ltd.)
Group A:The first cycle of the test preparation (fluticasone propionate aerosol inhalation suspension (2ml: 0.5mg) produced by Sichuan Prite Pharmaceutical Co., Ltd.)
Second cycle reference preparation (original GlaxoSmithKline Australia Pty Ltd. fluticasone propionate nebulized inhalation suspension (2ml: 0.5mg))
Sponsors
The Second Affiliated Hospital Of Xingtai Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Gender: male and female healthy subjects, and the enrolled subjects should have an appropriate sex ratio; 2. Age: Healthy subjects aged 18 years and above (including 18 years old); 3. Weight: male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, body mass index [BMI = weight (kg)/height^2 (m^2)] within the range of 19.0~26.0kg/m^2 (including boundary value); 4. Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form; 5. The subject can communicate well with the investigator, be trained to use the nebulizer device correctly, and be able to complete the study in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to any of the ingredients in fluticasone propionate and its related compounds and excipients, or those who are allergic to two or more drugs (or food); 2. Those who cannot comply with the uniform diet (such as intolerance to standard meals, etc.); 3. Those who cannot tolerate venipuncture, and those who have a history of fainting and blood sickness; 4. Those who have a history of major diseases such as cardiovascular, liver, kidney, endocrine, metabolic, digestive tract, blood system, respiratory system, urinary system, infection, malignant tumor, neuro-psychiatric system, etc., judged by the investigator to be abnormal and clinically significant, or those who have existing diseases above above; 5. Those who have undergone major surgical operations within 6 months before screening, or those who plan to undergo surgery during the trial, and those who have undergone surgeries that will affect the absorption, distribution, metabolism, and excretion of drugs (except for appendicitis surgery); 6. Those with a history of asthma or other respiratory diseases (active or inactive tuberculosis infection, a-1 antitrypsin deficiency, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary edema or pulmonary interstitial lesions, etc.) or airway hyperreactive; 7. Systemic fungal, bacterial, viral or parasitic infections that have not been treated or have not been cured after treatment, or ocular herpes simplex; 8. Those who are currently suffering from oral diseases (such as oral ulcers, oral mucosal damage, oral candidiasis, etc.); 9. Those who have suffered from glaucoma and cataract in the past or now; 10. Those who have physical examination, vital signs monitoring, electrocardiogram examination, chest CT examination, pulmonary function examination, and laboratory examination during the screening period, and the abnormalities are judged by the investigator to be clinically significant; 11. Those with abnormal test results of hepatitis B surface antigen, hepatitis C antibody, syphilis-specific antibody or AIDS antibody; 12. Those who have drunk excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup = 200mL) for a long time (within 3 months before screening) in the past; or those who ingested any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first dose of the trial; 13. Those who have ingested any beverage or food rich in xanthine or grapefruit or other beverages or foods that affect the absorption, distribution, metabolism, and excretion of drugs within 48 hours before the first dose of the test; 14. Use of any drugs that interact with fluticasone propionate within 4 weeks before screening (such as CYP3A4 inhibitors such as ketoconazole, ritonavir, etc.); 15. Those who have used long-acting estrogen or progesterone injections or implants within 6 months before the test; Those who have used short-acting contraceptives within 30 days before the trial; 16. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and health care products within 14 days before the first dose of the trial; 17. Those who smoke more than 5 cigarettes per day in the 3 months before screening, or those who have a positive smoking test before the first dose of the study, and those who cannot accept smoking prohibition after selection a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital Of Xingtai Medical College
Outcome results
None listed