chronic hepatitis
Conditions
Interventions
8:hypodermic
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Male subjects in the range of age from 18 to 40 years; 2. BMI within 19~24kg/m2, disparity of weirht body within ±10% for each group; 3. Subjects with normal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate and axillary temperature), Haemogram with ESR, Biochemistry, Infectious Disease Screening (HIV, Hepatitis B and Hepatitis C) and Urinalysis, ECG.,X-ray(chest); 4. Be in healthly, no history of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases; 5. Not be a smoker or an alcohol, and permitted no smoking and drink alcohol during the trial; 6. Willingness to follow the protocol requirement as evidenced by written, informed consent.
Exclusion criteria
Exclusion criteria: 1. With abnormal findings as determined by physical examination , vital signs and ECG. et al.; 2. History of chronic gastritis ,gastroenterocolitis or other medical conditions should affect the drug absorption, had known or suspected hypersensitive to the study drug; 3. Requiring medication for any ailment drugs in the previous 14 days; 4. Adminitrated study drug in the previous 60 days; 5. Participation in a clinical drug study or bioequivalence study 90 days prior to present study; 6. Blood donation 90 days prior to the commencement of the study; 7. History or presence of significant alcoholism or drug abuse in the past one year; 8. may be pregnancy during the trial, pregnancy and lactation woman; 9. History of any medical or surgical conditions in the previous 14 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| drug metablism dynamic; | — |
Countries
China
Contacts
Public ContactZhengli
Outcome results
None listed