Equivalence study
Conditions
Interventions
Two Groups:budesonide (1mg/2mL) for inhalation produced by Sichuan Puruite Pharmaceutical Technology Co., Ltd. versus the inhaled budesonide suspension produced by AstraZeneca Pty Ltd
Sponsors
Beijing Shijitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Health male and female, and the selected subjects should have an appropriate gender ratio; 2. Aged 18-65 years; 3. Male subjects should not be lower than 50.0kg, female subjects should not be lower than 45.0kg, body mass index [BMI = weight (kg) / height 2 (m2)] at 19.0 ~ 26.0kg / m2 In scope (including boundary values); 4. Subjects must give informed consent to the study prior to the trial and voluntarily sign written informed consent; 5. The subject is able to communicate well with the investigator and is able to complete the study in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: 1. those who are allergic to any component of the budesonide suspension and its related compounds and excipients, or who are allergic to two or more drugs (or foods); 2. Those who cannot follow a uniform diet (such as intolerance to standard meals); 3. can not tolerate venipuncture, there is a history of fainting halo; 4. There are medical history, liver, kidney, endocrine, metabolic, digestive tract, blood system, respiratory system, infection, malignant tumor, mental disorder and other medical history that the researcher judges to have clinical significance or existing diseases; 5. Those who have undergone major surgery within 6 months prior to screening, or who plan to undergo surgery during the study period, and those who have received surgery that affect drug absorption, distribution, metabolism, and excretion (except for appendicitis surgery); 6. Those with a history of peptic ulcer and intracranial hemorrhage; 7. Those with a history of asthma or high airway response; 8. active or inactive tuberculosis infection, untreated systemic fungal, bacterial, viral or parasitic infections; 9. Those with glaucoma and cataract in the past; 10. With oral diseases such as oral ulcers, oral mucosal damage, etc.; 11. physical examination during screening, vital signs monitoring, electrocardiogram examination, X-ray full chest orthotopic film, pulmonary function test, laboratory test (blood routine, urine routine, blood biochemistry, coagulation function, etc.), the researchers judged abnormal clinical Meaning person 12. Hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody or HIV antibody test results are clinically significant; 13. Drinking excessive (8 cups or more per day, 1 cup = 200mL) tea, coffee or caffeinated beverages in the long-term (within 3 months before screening); or ingesting any coffee containing coffee within 48 hours before the first dose For food or beverages (such as coffee, tea, chocolate, etc.); 14. Study any beverages or foods that are rich in jaundice or grapefruit or other substances that affect the absorption, distribution, metabolism, excretion, etc. of the drug within 48 hours before the first dose; 15. Any drug that interacts with budesonide has been used within 4 weeks prior to screening (eg CYP3A4 inhibitors such as ketoconazole, itraconazole, clarithromycin, erythromycin, etc., CYP1A2 inhibitor cimetidine Wait); 16. 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 test; 17. Study any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and health care products used within 14 days before the first dose; 18. More than 5 cigarettes per day for the first 3 months of screening, or those who are positive for smokers and those who are not allowed to accept smokers after the trial period; 19. Study the positive alcohol test results before the first dose, or drink more than 14 standard units per week for the first 6 months of screening (1 standard unit contains 14g alcohol, such as 360mL beer or 45mL alcohol with 40% spirits or 150mL wine); 20. Study the positive urine drug test before the first dose or the history of drug abuse (such as marijuana, benzodiazepine, ketamine, morphine, cocaine, methamphetamine) within 1 year before the test; 21. pregnant or lactating women or those who have a positive pregnancy test, as well a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactWang Xinghe
Beijing Shijitan Hospital, Capital Medical University
Outcome results
None listed