schizophrenia
Conditions
Interventions
I:Phase I: Clozapine Tablet manufactured by Qilu Pharmaceutical Co., Ltd.
Phase II: Clozapine Tablet manufactured by Qilu 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. Schizophrenia patients aged 18-65 years old inclusive with appropriate gender ratios; 2. Subjects have been taking a stable dose of clozapine tablets for up to 3 months and the daily dose is 150 to 350 mg; 3. Subjects (including male subjects) are willing to have no birth plans within the next 6 months and to take effective contraceptive measures; 4. Subjects or their legal guardians are able to communicate well with the researchers, understand and comply with the requirements of this study, as well as comprehend and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. A history of allergic reactions to clozapine; 2. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsons disease; 3. Having a medical history of epileptic seizures or epilepsy, encephalitis, hematopathy or severe cardiovascular diseases; 4. With a history of syncope; 5. A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic); 6. A history of orthostatic hypotension; 7. A history of drug abuse; 8. Acute illness occurs within one month before taking the drug in this study; 9. People who have participated in other drug or medical device trials within 3 months before the test or people who are participating in other clinical trials; 10. Those who have donated blood or bled heavily (>=200mL), received blood transfusions or used blood products within 3 months before the test; 11. Obvious tobacco and alcohol addiction within one year before the trial [20 cigarettes per day; drinking more than 14 unit alcohol per week (1 unit = 285 mL beer or 25 mL spirits with 40% alcohol or 100 mL wine) ]; 12. drug screening test is positive while screening or at baseline; 13. abnormal vital signs examination shows clinical significance, referring to the normal range (sitting systolic blood pressure is 90-140mmHg, diastolic blood pressure is 50-90mmHg, pulse is 50-100 beats/min and the forehead temperature is 35.4-37.7 degree C inclusive). Specific situation is determined by the investigator comprehensively; 14. Any of the laboratory examination items shows is clinically significant and investigator judge those who need to be excluded; 15. A total white blood cell count below 4x10^9/L, or an absolute neutrophil count below 2x10^9/L; 16. Women who are pregnant or breast-feeding or people who are unable to be contraceptive as required; 17. Those who have special dietary requirements and cannot accept a unified diet; 18. Those under other circumstances who are judged unsuitable for this research by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clozapine in plasma; | — |
Countries
China
Contacts
Public ContactPingfei Fang
Department of Pharmacy, the Second Xiangya Hospital, Central South University
Outcome results
None listed