asthma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) healthy subjects over 18 years old (including 18 years old), both male and female; (2) male weight 50.0kg, female weight 45.0kg; Body mass index (BMI) was 19.0~26.0kg/m2 (including boundary value). (3) medical history, vital signs, physical examination, blood routine, urine routine, blood biochemistry, chest X-ray, electrocardiogram and lung function examination before the test were normal or abnormal without clinical significance; (4) subjects and their partners will be able to take effective contraceptive measures during the study period and have no family planning during the study period and within 6 months after the study period; (5) after training during the screening period, patients can perform respiratory movements as required during oral inhalation administration; (6) fully understand and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1) have been enrolled in clinical trials of other drugs in the past 3 months; (2) have donated blood or lost blood of 400mL or more within the past 3 months; (3) patients with a history of any serious clinical diseases such as respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, nervous system or mental disorder or any other diseases or physiological conditions that may interfere with the test results. (4) patients with asthma or other respiratory diseases, such as: active or inactive tuberculosis infection, -1 antitrypsin deficiency, cystic fibrosis, chronic obstructive pulmonary disease, positive bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary edema or pulmonary interstitial lesions; (5) infectious diseases, such as systemic fungal, bacterial, viral or parasitic infections, within the past 2 months; (6) patients with peptic ulcer and glaucoma; (7) is suffering from oral diseases such as oral ulcer, oral mucosa damage, etc.; (8) patients with a history of major surgery in the past 3 months; (9) positive for hepatitis b surface antigen, treponema pallidum antibody, human immunodeficiency virus or hepatitis c virus antibody; (10) have a history of drug, food or other allergy, known or suspected to have a history of allergy to betamethasone propionate or its projectile (tetrafluoroethane), or other adrenal glucocorticoid allergy; (11) have a smoking habit (at least 5 cigarettes per day) within 3 months or cannot stop using any tobacco products during the study period; (12) positive screening of tobacco; (13) those with positive breath test of alcohol or regular drinkers in the past 6 months, that is, those who drink more than 14 units of alcohol per week (1 unit =285mL beer or 25mL spirit or 100mL wine with 40% alcohol); (14) patients with a history of drug abuse or positive drug abuse screening within the past 6 months; (15) have taken any prescription drugs, over-the-counter drugs, vitamin products or Chinese herbal medicines within the past 2 weeks; (16) eat fruits that affect drug metabolism, such as dragon fruit, mango, grapefruit, or foods rich in xanthine, and/or drink caffeine-rich beverages, such as chocolate, tea, coffee, cola, etc. within 48 hours before administration; (17) patients who cannot tolerate venipuncture and have a history of blood and needle sickness; (18) women during pregnancy and lactation; (19) those who have special dietary requirements and cannot accept a unified diet; (20) cannot tolerate activated carbon; (21) the researchers considered that others should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Secondary
| Measure | Time frame |
|---|---|
| lung function;Blood coagulation function; | — |
Countries
China
Contacts
Beijing Shijitan Hospital Capital Medical University