Schizophrenia
Conditions
Interventions
I:Phase I: Clozapine dispersible Tablet manufactured by Shouguang Fukang Pharmaceutical Co.,Ltd.
Phase II: Clozapine dispersible Tablet manufactured by Shouguang Fukang Pharmaceutical Co.,Ltd.
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Schizophrenic subjects aged from 18 to 65 years (including critical value) with appropriate sex ratio; 2. Subjects who had been taking clozapine for 3 months or had been taking clozapine for more than 3 months before the start of the trial (before enrollment), and the daily dose was 150-350 mg; 3. During the study period, clozapine dosage can be stabilized at 100mg / time, once every 12 hours, and the disease can be controlled stably; 4. The subjects who had no family planning within 2 weeks before and 6 months after the trial and agreed to take effective non drug contraceptive measures during the trial were screened; 5. The subjects or their legal guardians who can communicate well with the researchers understand and comply with the requirements of this study, understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of allergy to clozapine; 2. Patients with complicated mental or neurological diseases, including organic mental disorders, severe tardive dyskinesia or congenital Parkinson's disease; 3. Patients with history of epileptic seizure or epilepsy or severe diseases such as encephalitis, blood diseases and cardiovascular system; 4. Patients with multiple syncope episodes; 5. Patients with a history of agranulocytosis or myelodysplasia (drug-induced or congenital); 6. Patients with history of orthostatic hypotension; 7. Patients with a history of drug abuse or drug abuse; 8. Patients with acute gastrointestinal diseases, acute liver and kidney diseases, acute metabolic diseases and acute endocrine diseases within one month before the trial; 9. Those who have participated in other drug or medical device trials or are participating in other clinical trials within 3 months before the trial; 10. The subjects who donated blood or lost a lot of blood (>= 200ml), received blood transfusion or used blood products within 3 months before the experiment; 11. Subjects with obvious habit of smoking and drinking in one year before the experiment [smoking more than 20 cigarettes per day; drinking more than 14 units of alcohol per week (1 unit = 285ml beer or 25ml spirits with 40% alcohol or 100ml wine)]; 12. Patients with positive drug screening at screening or baseline; 13. For the subjects with abnormal vital signs that need to be excluded according to the judgment of the researcher, the reference normal value range is: sitting systolic blood pressure 90 ~ 140mmHg, diastolic blood pressure 50 ~ 90mmHg, pulse 50 ~ 100bpm, body temperature (frontal temperature) 35.4 ~ 37.2 degree C (including the critical value), and the specific situation is comprehensively determined by the researcher; 14. Subjects whose laboratory test values are abnormal and have clinical significance and need to be excluded according to the judgment of researchers; 15. Subjects whose WBC count is less than 4 x 10^9 / L, or neutrophil absolute count is less than 2 x 10^9 / L; 16. Pregnant or lactating women or subjects who can not use contraception as required; 17. Subjects who have special dietary requirements and cannot accept the same diet; 18. Subjects who are judged by the researcher to be unsuitable for the study in other circumstances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clozapine in plasma; | — |
Countries
China
Contacts
Public ContactPingfei Fang
Department of pharmacy, Second Xiangya Hospital of Central South University
Outcome results
None listed