schizophrenia
Conditions
Interventions
Single dose group B:In the fasting state, oral dose of 8mg, then 12mg, and finally 4mg
Single dose group A:In the fasting state, oral dose of 4mg, then 8mg, and finally 12mg
Single dose group C:In the fasting state, oral dose of 12mg, then 4mg, and finally 8mg
Multiple dose group :Given 4mg twice a day, till 9 times
Effect of feeding group A:Single oral dose of 4mg in the fasting state, then single oral dose of 4mg in the fed state
Effect of feeding group B:Single oral dose of 4mg in the fed state, then single oral dose of 4mg in the fasting state
Sponsors
The first affiliated hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
20 Years to 29 Years
Inclusion criteria
Inclusion criteria: 1) Healthy subject; 2) Subject is 18~45 years old and the age difference should less than 10 years in the same batch; the sexual portion is equal; 3) BMI in range of 19~25kg/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 objectnature and eventuality of trial, volunteer for the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Allergic constitution: The persons allergy for investigator product, food, pollen or ingredients of investigator product (analogue); 2) Participate other clinical trial in the last 3 months; 3) Blood donation in the last 3 month or intend to donate blood in the following 1 month; 4) Used any medicine in the last 2 weeks; 5) Any medical history of cardiovascular, hepatic, kidney, gastrointestinal tract, and nervous system, metabolic disturbance, etc; 6) The general examination and blood pressure, heart rate and respiratory conditions are not qualified; 7) Physical examination found that there are any significant clinical symptoms; 8) Laboratory test (hematology, urine analysis, blood biochemistry, ECG examination and the four markers) results judged as clinical significance of abnormal; 9) Drug abusers, tobacco and alcohol addiction; 10) Menstruation, pregnancy and lactation women; 11) Subject cant complete the trial because of other reasons or unsuitable to participate in the trial considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCtn;Cmax;Tmax;Tmax;t1/2z;CLz;Vz;AUCss;Css_min;Cavg;fluctuation%; | — |
Countries
China
Contacts
Public ContactJianzhong Shentu
Outcome results
None listed