schizophrenia
Conditions
Interventions
T-R:Delivery order: test preparation-reference preparation
R-T:Delivery order: reference preparation-test preparation
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-65 years (including critical value) with appropriate sex ratio; 2. Conforming to DSM-5 criteria for schizophrenia; 3. Subjects have taken a stable dose of clozapine for up to 3 months at a daily dose of 150 to 350 mg and are able to tolerate 100 mg every 12 hours during the study; 4. Subjects (including male subjects) are willing to have no birth plans within the next 6 months and to take effective contraceptive measures; 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 a history of agranulocytosis or myelodysplasia (drug-induced or congenital); 4. Patients with history of epileptic seizure or epilepsy or severe diseases such as encephalitis, blood diseases and cardiovascular system; 5. Patients with history of orthostatic hypotension; 6. Patients with multiple syncope episodes; 7. Patients with a history of 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. Significant drinking habits within 1 year before the test (drinking more than 14 units of alcohol per week, 1 unit >= 200 mL of 5% alcohol beer or 25 mL of 40% alcohol spirits or 85 mL of 12% alcohol wine); 10. Smoking > 20 cigarettes per day within 1 year before the test; 11. Subjects who have participated in other drug or medical device trials within 3 months before the trial; 12. The subjects who donated blood or lost a lot of blood (>= 400mL); 13. Pregnant or lactating women; 14. Subjects who cannot accept the same diet; 15. 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 ~ 139mmHg, diastolic blood pressure 60 ~ 89mmHg, pulse 60 ~ 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; 16. Subjects whose laboratory test values are abnormal and have clinical significance and need to be excluded according to the judgment of researchers; 17. Subjects whose WBC count is less than 4 x 10^9 / L, or neutrophil absolute count is less than 2 x 10^9 / L; 18. ECG or physical examination are abnormal and the doctor considers it is not suitable to participate in the study; 19. Those under other circumstances who are judged unsuitable for this research by the researchers; 20. According to the judgment of the researcher, other conditions are not suitable to participate in the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clozapine in plasma; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactPingfei Fang
the Second Xiangya Hospital, Central South University
Outcome results
None listed