Depression
Conditions
Interventions
A:30 mg po. (reference), washout 14 days, 30 mg po(test)
B:30 mg po.(test), washout 14 days, 30 mg po (reference)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Willingness to follow the protocol requirement as evidenced by written, informed consent; 2. Male subjects in the range of age from 18 to 40 years; 3. Weight body above 50 kg, BMI within 19~25kg/m2, disparity of weirht body within ±10% for each group; 4. Be in healthly, no history of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases; 5. 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.
Exclusion criteria
Exclusion criteria: 1. History of any medical or surgical conditions in the previous 14 days; 2. Adminitrated study drug in the previous 56 days .3. Requiring medication for any ailment drugs in the previous 14 days; 4. Had known or suspected hypersensitive to the study drug; 5. History of chronic gastritis, gastroenterocolitis or other medical conditions should affect the drug absorption; 6. History of hypersensitivity disease and asthma; 7. History or presence of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases; 8. With abnormal findings as determined by physical examination, vital signs and ECG; 9. History or presence of significant alcoholism or drug abuse in the past one year; 10. Participation in a clinical drug study or bioequivalence study 90 days prior to present study; 11. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests; 12. Blood donation 90 days prior to the commencement of the study; 13. Smokers and moderate smokers will be excluded. "Moderate smokers are defined as someone smoking 5 cigarettes or less per day, ex smokers are someone who completely stopped smoking for at least 2 weeks"; 14. Investigator think the subject too poor in compliance to complete the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(0-infinite);AUC(0-t);Cmax; | — |
Countries
China
Contacts
Public ContactZhengli
Outcome results
None listed