schizophrenia
Conditions
Interventions
A:The volunteers was given 1 mg*2 Risperidone dispersible tablets in first cycle, and 1 mg*2 Risperidone tablets in second cycle.
B:The volunteers was given 1 mg*2 Risperidone tablets in first cycle , and 1 mg*2 Risperidone dispersible tablets in second cycle.
C:The volunteers was given 1 mg*2 Risperidone dispersible tablets after breakfast in first cycle , and 1 mg*2 Risperidone tablets after breakfast in second cycle.
D:The volunteers was given 1 mg*2 Risperidone tablets after breakfast in first cycle , and 1 mg*2 Risperidone dispersible tablets after breakfast in second cycle.
Sponsors
The first affiliated hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male subject; 2. Subject is 18~45 years old and the age difference should less than 10 years in the same batch; 3. BMI in range of 19~24kg/m2 [BMI=weight (kg)/height 2(m2)]; 4. Subject is able to communicate with investigator well and comply with requires of study; 5. Subject should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Specific allergic history (asthma, measles, eczema et.al); Allergic constitution: The persons allergy for investigator product, food, pollen or ingredients of investigator product (analogue); 2. Laboratory test (hematology, urine analysis, blood biochemistry) results 2 weeks before trial judged as clinical significance of abnormal; 3. Any history of severe disease or medical history of cardiovascular system, endocrine system, nervous system, lung, hematology, immunology, pathergasiology and metabolic disturbance; 4. Physical examination and 12-lead electrocardiogram results before trial judged as clinical significance of abnormal; 5. HIV, HBV, HCV, TP-Anti positive; 6. Suffering clinical severe disease or surgery 4 weeks before trial; 7. Participate other clinical trial in the last 3 months; 8. Blood donation in the last 3 month or intend to donate blood in the following 1 month; 9. Used any medicine in the last 2 weeks; 10. Frequently drinking 6 months before trial, averagely get above 14 units alcohol every week (1 unit=beer 360mL or 40% liquor 45mL or wine 150mL); 11. Taking the soft drugs (ecstasy, Ken powder, MaGu et.al) 3 months before trial or hard drugs (cocaine, heroin, meth et.al) 1 year before trial; 12. Averagely take above 1 cigarette a day at the last 3 months; 13. Special requirements for food, refuse to comply with unified diet; 14. Drinking too much tea, coffee or/and drinking with caffeine (averagely 200mL *8 cups a day); 15. Subject can't complete the trial because of other reasons or unsuitable to participate in the trial considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;AUC0-t;AUC0-Infinite;t1/2;CLz/F; | — |
Countries
China
Contacts
Public ContactShentu Jianzhong
Outcome results
None listed