bronchial asthma
Conditions
Interventions
Group 1:25 mg
Group 2:50mg
Group 3:100mg
Group 4:200mg
Group 5:400mg
Group 6:600mg
Group 7:800mg
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, overall healthy subjectsfemale VS male 1:1 ratio; 2. Between 18 and 45 years of age, inclusive, similar ages; 3. Body weight should be=50 kg; Body Mass Index (BMI) is between 19.0 and 28.0 kg/m2, inclusive; 4. Able to comprehend and sign the ICF voluntarily prior to initiate the study; 5. Able to communicate well with the investigator and complete the study according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing female, or plan for pregnancy within 6 months; 2. A clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratoryresults at screening; 3. Has a positive test for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody A clinically significant abnormal finding on HBV-DNA test ; 4. Sitting systolic blood pressure (SBP) 140mmHg, and/or sitting diastolic blood pressure (DBP) 90mmHg at screening; 5. With the history of using any drug which will inhibit or induce liver metabolize drug and/or will infect gastric acid within 1 month before randomization; 6. Receipt of any medication including over the counter preparations and vitamins within 14 days of the first study day; 7. History of cardiovascular, immune system, Severe digestive system, Circulatory system, respiratory system, urinary system , nervous system,tumor diseases; 8. Suffering from blood diseases such as coagulopathy; 9. Patients with a history of mental illness or active mental illness; 10. Have undergone major surgery within 6 months before enrollment; 11. A history of gastrointestinal, liver ,kidney diseases likely to influence drug absorption within 6 months before enrollment; 12. Drug or alcohol abuse; 13. History of drug abuse and drug use within 1 year prior to the study; 14. Habitual consumption of grapefruit juice, tea, coffee and/or caffeinated beverages, which cannot be withdrawn during the trial; 15. The average daily smoking volume is >5 within 3 months prior to the study; 16. A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or related drugs or excipients employed in this study; 17. Participation in a clinical study within 3 months of the first dose of study drug; 18. Donation of blood within 3 months of the first dose of study drug or have a plan to donate blood; 19. Cannot be tolerant to oral drugs; 20. Poor peripheral venous access conditions; 21. The investigator believes that it should not be included; 22. Additional exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Respiration;ECG;Temperature;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed