schizophrenia
Conditions
Interventions
I:Phase 1:Test product 100mg, Phase 2: Reference product 100mg
II:Phase 1: Reference product 100mg, Phase 2: Test product 100mg
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 225 mg; 3. Subjects had no clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, metabolic, endocrine, or immune diseases, and overall health is good; 4. Subjects (including male subjects) are willing to have no birth plans within the next 6 months and to take effective contraceptive measures; 5. 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 or other chemically related psychotropic drugs; 2. Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinsons disease; 3. A total white blood cell count below 4×10^9/L, or an absolute neutrophil count below 2×10^9/L; 4. A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic); 5. Having a medical history of epileptic seizures or epilepsy, encephalitis, hematopathy or severe cardiovascular diseases; 6. With a history of syncope; 7. Acute illness occurs within one month before taking the drug in this study; 8. Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing); 9. Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension; 10. Having conditions or a surgical history those may affect the absorption, distribution, metabolism or excretion of clozapine, or a medical history related to the effect of the investigational product, and any other conditions; 11. The inducer or inhibitor of CYP1A2, CYP3A4 or CYP2D6 enzyme is needed to be taken during the study, such as fluvoxamine, cimetidine, sertraline, etc.; 12. Taking drugs that would increase QT interval during the study, such as ziprasidone, erythromycin, quinidine, methadone, etc.; 13. Concurrent use of other drugs known to suppress bone marrow function; 14. The concomitant drug use may change during the study; 15. 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; 16. Any of the laboratory examination items shows abnormality and is clinically significant judging by the investigator; 17. Any of alcohol breath test, cigarette smoke test, or drug screening test is positive while screening or at baseline; 18. Obvious tobacco and alcohol addiction within one year before the trial [5 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) ]; 19. A history of drug abuse; 20. 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; 21. Those who have donated blood or bled heavily (=200mL), received blood transfusions or used blood products within 3 months before the test; 22. Women who are pregnant or breast-feeding or people who are unable to be contraceptive as required; 23. Those who have special dietary requirements and cannot accept a unified diet; 24. 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