chronic obstructive pulmonary disease
Conditions
Interventions
group A:T-R-T-R
Test preparation (T): budesonide formoterol inhalation aerosol, the specification is the main drug content per bottle: 120 bottles per bottle, 181 µg of budesonide per bottle, 5.1 µg o
group B:R-T-R-T
Test preparation (T): budesonide formoterol inhalation aerosol, the specification is the main drug content per bottle: 120 bottles per bottle, 181 µg of budesonide per bottle, 5.1 µg o
Sponsors
Beijing Shijitan Hospital, Capital Medical University
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 gender ratio; 2. Age: > = 18 years old (including 18 years old); 3. Weight: the weight of male subjects >=50.0kg, the weight of female subjects >=45.0kg, and the body mass index (BMI=weight (kg)/height²(m²)) is within the range of 19.0~26.0kg/m² (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 aerosol 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 budesonide formoterol inhalation aerosol and any of its related compounds and excipients, or allergic to two or more drugs (or food); 2. Those who cannot comply with a uniform diet (such as intolerance to standard meals, etc.); 3. Those who cannot tolerate venipuncture, and those who have a history of dizziness and blood sickness; 4. Those who have a history of residence or travel in the epidemic area and a history of close contact with confirmed or suspected patients within 14 days before screening; 5. Those who have a history of cardiovascular, liver, kidney, endocrine, metabolic, digestive tract, blood system, respiratory system, infection, malignant tumor, mental abnormality and other diseases judged by the investigator to be clinically significant, or those who have the above diseases; 6. Those who have a history of hyperthyroidism in the past or abnormal thyroid function tests during the screening period and are clinically significant; 7. Those who have undergone major surgical operations within 6 months before screening, or those who plan to undergo surgery during the study period, and those who have undergone surgery that will affect the absorption, distribution, metabolism and excretion of drugs (except for appendicitis surgery); 8. Those with a history of asthma or airway hyperresponsiveness; 9. Patients with active or inactive pulmonary tuberculosis infection, untreated systemic fungal, bacterial, viral or parasitic infection, or ocular herpes simplex; 10. Those who have suffered from glaucoma and cataract in the past or now; 11. Those who are suffering from oral diseases (such as oral ulcers, oral mucosal damage, etc.); 12. During the screening period, physical examination, vital signs monitoring, electrocardiogram examination, chest CT, pulmonary function test, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, etc.), and the investigator judged that the abnormality is clinically significant; 13. Patients with abnormal test results of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody or HIV antibody with clinical significance; 14. Those who have drunk excessive amounts of tea, coffee or caffeinated beverages for a long time (more than 8 cups a day, 1 cup = 200mL) for a long time (within 3 months before screening) in the past; or those who have ingested any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first dose of the study; 15. Those who have ingested any beverage or food rich in xanthine or grapefruit or other substances that affect the absorption, distribution, metabolism, and excretion of drugs within 48 hours before the first dose of the study; 16. Have used any drugs that interact with budesonide and formoterol (such as CYP3A4 inhibitors (such as ketoconazole, itraconazole, clarithromycin, erythromycin, etc.), monoamine oxidase inhibitors and drugs with similar characteristics (such as furazolidone and procarbazine), tricyclic antidepressants, ß-adrenergic receptor blockers (including eye drops), other ß-adrenergic receptor agonists, antihistamines, diuretics, etc.); 17. Those who have used long-acting estrogen or progesterone injections or implanted tablets within 6 months before the test; Those who have used short-acting contraceptives within 30 days before the trial; 18. Those who have used any prescription drugs, over-the-counter drugs, Chinese herb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t, AUC0-8, Cmax, t1/2, ?z, Tmax and AUC_%Extrap; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety index: Adverse events, Vital signs, Physical examination, ECG, Laboratory examination; | — |
Countries
China
Contacts
Public ContactWang Xinghe
Beijing Shijitan Hospital, Capital Medical University
Outcome results
None listed