Chronic respiratory diseases
Conditions
Interventions
Group A:Test preparation (T) was given in the first cycle, and reference preparation (R) was given in the second cycle after 21 days of cleaning.
Group B:Reference preparation (R) was given in the first cycle, and test preparation (T) was given in the second cycle after 21 days of cleaning.
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years (including the critical value), no gender limit; 2. Weight of male volunteers >=50.0 kg, weight of female volunteers >=45.0 kg, body mass index (BMI) between 19 and 26 kg/m^2, including the cut-off value; 3. The subject (including the male subject) has no fertility plan, sperm or egg donation plan and voluntarily takes effective physical contraception during and within 90 days after the trial; 4. Voluntarily sign written informed consent; 5. Subjects should be able to communicate well with the researcher, use the powder device correctly, and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. The subject has a history of allergy or allergy to indacat rogron bromide or its analogues or its excipients (multiple drug and food allergies); 2. Subjects are experiencing or have a history of chronic bronchitis, emphysema, asthma, or other clinically significant lung and liver diseases; 3. Pregnancy and/or abnormal serum pregnancy tests with clinical significance, or lactation; 4. Those who had taken a special diet (including grapefruit, chocolate, xanthine food/drink) within 48 hours before the first dose of the trial and/or consumed excessive tea, coffee, grapefruit/grapefruit juice, grapefruit juice, and caffeinated drinks (an average of more than 8 cups per day, 200 mL per cup) in the past three months; 5. Subjects who have taken any medication (including vitamin products and Chinese herbal medicines) within 14 days prior to the trial; 6. Use of any drug that inhibits or induces liver metabolism of the drug within 1 month prior to the trial (e.g. : inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 7. Subjects who have taken other clinical trial drugs within three months before the trial; 8. Subjects who donated blood or suffered massive blood loss (>=200mL, excluding menstrual blood loss), received blood transfusion or used blood products within three months before the trial; 9. The subjects tested positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV) and Treponema pallidum antibody; 10. Smokers or those who smoked more than 5 cigarettes a day in the three months before the test, or who tested positive for nicotine; 11. Subjects who were screened positive for alcohol expiratory or drug abuse before the test; 12. The subject had a history of drug use or alcohol abuse in the 6 months prior to the trial, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); 13. Subjects with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90mmHg, heart rate 100bpm), or physical examination, electrocardiogram, laboratory examination, pulmonary function test, chest radiograph, which were judged by clinicians to be clinically significant; 14. Lung function test: FEV1 measured value/FEV1 predicted value <=80% or FVC<= 80% of predicted value; 15. Received inactivated vaccine within 1 month before screening, received live/attenuated vaccine within 3 months before screening or planned to receive inactivated/live/attenuated vaccine during the trial; 16. Those who should not be included for other reasons considered by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Outcome results
None listed