The treatment of mild to moderate acute asthma attacks in children and adolescents aged 4-16 years old.
Conditions
Interventions
A Group:T1T2R
B Group:RT1T2
C Group:T2RT1
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 selected subjects should have an appropriate gender ratio; 2) Age: Healthy subjects aged 18 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, and body mass index [BMI=weight (kg)/height^ 2 (m^2)] should be within the range of 19.0~26.0kg/m^2 (including boundary values); 4) Participants must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form; 5) The subjects are able to communicate well with the researchers, have been trained to correctly use the nebulizer device, and are able to complete the study in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: 1) Individuals allergic to any component of fluticasone propionate and its related compounds and excipients, or allergic to two or more drugs (or foods); 2) Those who cannot adhere to a standardized diet (such as intolerance to standard meal foods); 3) Individuals who cannot tolerate venipuncture and have a history of needle and blood dizziness; 4) There are significant medical histories or existing diseases of cardiovascular, liver, kidney, endocrine, metabolic, digestive, hematological, respiratory, urinary, infectious, malignant tumors, and neuro psychiatric systems that researchers have determined to be clinically significant abnormalities; 5) Individuals who have undergone major surgical procedures within the 6 months prior to screening, or who plan to undergo surgery during the trial period, as well as those who have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion (excluding appendectomy surgery); 6) Individuals with a history of asthma or other respiratory diseases (active or inactive tuberculosis infection, alpha-1 antitrypsin deficiency, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, sarcoidosis, pulmonary fibrosis, pulmonary arterial hypertension, pulmonary edema or interstitial lung disease, etc.) or airway hyperresponsiveness; 7) Untreated or untreated systemic fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex; 8) Individuals currently suffering from oral diseases (such as oral ulcers, oral mucosal damage, oral candidiasis, etc.); 9) Individuals who have previously or currently suffered from glaucoma or cataracts; 10) Screening period physical examination, vital sign monitoring, electrocardiogram examination, chest CT examination, lung function examination, laboratory examination, and those judged by researchers to have clinical significance for abnormalities; 11) Abnormal test results of hepatitis B surface antigen, hepatitis C antibody, syphilis specific antibody or AIDS antibody; 12) Individuals who have consumed excessive amounts of tea, coffee, or caffeinated beverages (8 or more cups per day, 1 cup=200mL) in the past 3 months prior to screening; Those who consume any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first use of the drug in the trial; 13) Individuals who have consumed any beverages or foods rich in xanthine or grapefruit or other substances that affect drug absorption, distribution, metabolism, excretion, etc. within 48 hours prior to the first use of the trial medication; 14) Have used any drugs that interact with fluticasone propionate within the previous 4 weeks of 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 experiment; Individuals who have used short acting contraceptives within the 30 days prior to the trial; 16) Individuals who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements within 14 days prior to the first use of the trial medication; 17) Individuals who smoke more than 5 cigarettes per day in the first 3 months of screening, or those who test positive for cigarettes before the first use of the study, as well as those who cannot accept smoking bans from enrollment to the entire trial period; 18) The alcohol breath test result is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax?AUC0-t?AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, t1/2, ?z, AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactFengxue Guo
The Second Affiliated Hospital Of Xingtai Medical College
Outcome results
None listed