chronic obstructive pulmonary disease
Conditions
Interventions
Healthy subjects:roflumilast
Sponsors
The first hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers; 2. Healthy volunteers between 18 and 40 years of age; 3. body weight >=50kg, and Body Mass Index (BMI) between 19-24kg/m2 with similar weight; 4. No clinically significant laboratory abnormality or other clinical findings indicative of disease (including but not limited to renal, hepatic, gastrointestinal, cardiovascular, neurological disease; 5. Ability to understand and provide written informed consent and voluntary consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening(including but not limited to blood pressure,ECG abnormality,a positive hepatitis screen including hepatitis B surface antigen (HBsAg) and hepatitis C/HIV antibody); 2. Drug , alcohol abuse and smoking history in the past year; 3. Participation in another clinical trial within 3 months; 4. Use of any prescription drug therapy within 14 days prior to receiving study drug; 5. A history of hypersensitivity to any drug,especially to roflumilast; 6. Donation or loss of a significant volume of blood or plasma (> 500 mL) within 3 months or intention to donation during study period; 7. A history of postural hypotension; 8. not acceptable of venous puncture sampling; 9. History of difficulties in swallowing; 10. have birth plan within 3 months during or after completing the study; 11. A positive result of pregnancy test; 12. Not able to understand and provide written informed consent and voluntary consent to participate in the study; 13. Consumption of any caffeine-containing foods or beverages within 48 hours prior to receiving study drug; 14. A history of depressive disorder or suicidal tendency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood pressure; | — |
Countries
China
Contacts
Public ContactCuiyun Li
Outcome results
None listed