Equivalence study
Conditions
Interventions
Subject preparation group:Cross - administration during the week
Cross over during the week:Cross - administration during the week
Sponsors
Beijing Shijitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Gender: male and female healthy subjects, and the selected subjects should have appropriate gender ratio; 2. Healthy subjects aged 18-65 (including boundary value); 3. Body weight: male subjects should not be less than 50.0 kg, female subjects should not be less than 45.0 kg, body mass index [BMI = weight (kg) / height 2 (M2)] should be in the range of 19.0-26.0 kg / m2 (including the boundary value); 4. The subjects must give informed consent to the study before the trial and sign the written informed consent voluntarily; 5. The subjects can communicate well with the researchers and complete the study according to the research regulations.
Exclusion criteria
Exclusion criteria: In case of any of the following conditions, the test can not be selected: 1. Objects allergic to budesonide suspension for inhalation and its related compounds and excipients, or allergic to two or more drugs (or food); 2. Those who can't abide by the unified diet (such as intolerance to standard food, etc.); 3. Those who can't tolerate venipuncture have a history of needle syncope and blood syncope; 4. There are patients with clinical significant cardiovascular, liver, kidney, endocrine, metabolism, digestive tract, blood system, respiratory system, infection, malignant tumor, mental disorder and other major medical history or patients with the above diseases judged by researchers; 5. Patients who have undergone major surgical operation within 6 months before screening, or those who plan to have surgery during the study period, and those who have received surgery that will affect drug absorption, distribution, metabolism and excretion (except appendicitis surgery); 6. During the screening period, physical examination, vital signs monitoring, electrocardiogram, chest CT, pulmonary function test, laboratory examination (blood routine, urine routine, blood biochemical, coagulation function, etc.), the researchers judged the patients with abnormal clinical significance; 7. Patients with abnormal HBsAg, HCV antibody, Treponema pallidum antibody or HIV antibody with clinical significance; 8. Those who have been drinking tea, coffee or caffeinated drinks for a long time (more than 8 cups a day, 1 cup = 200ml) for a long time (within 3 months before screening); or those who have consumed any food or drink containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first medication; 9. Within 48 hours before the first administration of the study, any drink or food rich in xanthine or grapefruit or other substances that affect the absorption, distribution, metabolism and excretion of drugs have been ingested; 10. Patients who have used any drugs that interact with budesonide within 4 weeks before screening (such as CYP3A4 inhibitors such as ketoconazole, itraconazole, clarithromycin, erythromycin, CYP1A2 inhibitor, cimetidine, etc.); 11. Patients who have used long-acting estrogen or progesterone injections or implants within 6 months before the trial, and those who have used short acting contraceptives within 30 days before the trial; 12. Patients who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products within 14 days before the first medication of the study; 13. Those who smoked more than 5 cigarettes a day in the three months before screening, or those who were positive for smoking test, and those who were selected from the study to the whole test period could not accept the ban of smoking; 14. Patients with positive alcohol test results before the first drug administration in the study, or drinking more than 14 standard units per week in the 6 months before screening (1 standard unit contains 14 g alcohol, such as 360 ml beer or 45 ml alcohol with 40% alcohol content or 150 ml wine); 15. Patients with positive urine screening for drug abuse before the first drug use of the study or with a history of drug abuse within one year before the trial (such as cannabis, benzodiazepine, ketamine, morphine, cocaine, methamphetamine); 16. Pregnant or lactating women or their blood pregnancy test positive counterparts, and male subjects (or their partners)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactWang Xinghe
Beijing Shijitan Hospital Affiliated to Capital Medical University
Outcome results
None listed