Bronchospasm
Conditions
Interventions
A:test-reference
B:reference-test
Sponsors
The Third Xiangya Hoapital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-45 years (including threshold), both male and female; 2. The body weight of male volunteers >= 50.0 kg, female volunteers >= 45.0 kg, body mass index (BMI) between 19 and 26 kg/ m2, including the critical value; 3. During the trial period (including male subjects) and within 90 days after the end of the trial, the subjects had no birth plan, donated sperm or egg plan and voluntarily took effective physical contraceptive measures; 4. Volunteers voluntarily sign written informed consent. 5. The subjects can communicate well with the researchers, use the powder spray device correctly, and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: Volunteers who meet one or more of the following criteria will be excluded: 1. Subjects with allergic history or constitution to salbutamol or its analogues or its auxiliary materials (multiple drugs and food allergies); 2. The subjects are experiencing the following conditions or have the following history: chronic bronchitis, emphysema, asthma, or other clinically significant lung and liver diseases; 3. Pregnancy and / or serum pregnancy were positive, or lactating women; 4. Patients who had taken special diet (including grapefruit, chocolate, food / drink containing xanthine) within 48 hours before the first administration of the trial and / or drank excessive tea, coffee, grapefruit / grapefruit juice, grapefruit juice, caffeinated beverage every day for nearly three months (average more than 8 cups per day, 200ml per cup); 6. Patients who have used any drugs to inhibit or induce liver metabolism within one month before the trial (such as inducers barbiturates, carbamazepine, phenytoin, glucocorticoids, Omeprazole; inhibitors SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines)) 7. The subjects have taken other clinical trial drugs within three months before the trial; 8. Subjects who donate blood or lose a lot of blood (>= 200ml) within three months before the test and receive blood transfusion or use blood products; 9. HBsAg, anti HCV, anti HIV and RPR were positive; 10. Nicotine test was positive in smokers or patients who smoked more than 5 cigarettes per day three months before the test; 11. The subjects were positive in alcohol breath or drug abuse screening before the test; 12. The subjects had a history of drug abuse or alcohol abuse within 6 months before the trial, that is, drinking more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of spirits or 150 ml of wine with 40% alcohol); 13. Patients with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg, heart rate 100 BPM), or physical examination, ECG, laboratory examination, pulmonary function examination, chest X-ray examination determined by clinicians as abnormal and clinically significant; 14. Pulmonary function test: FEV1 measured value / FEV1 predicted value <= 80% or FVC <= 80% of predicted value; 15. For other reasons, researchers believe that they should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYang Guoping
Clinical trial research center, Xiangya Third Hospital, Central South University
Outcome results
None listed