Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Paliperidone Palmitate prolonged-release suspension
For injection 100 mg of Qilu Pharmaceuticals Co., Ltd.
: Dose: 100 mg,
Frequency: Monthly,
Route of Administration: Intramuscular,
D
Sponsors
Qilu Pharmaceuticals Co., Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent prior to any study-related activities being performed and to follow the protocol requirements. 2. Male and female subjects aged 18-65 years (both inclusive) having body mass index between 18.50 to 30.00 kg per m2 (both inclusive). 3. Subjects diagnosed with schizophrenia as per DSM-5-TR criteria or later. 4. Schizophrenic subjects who are clinically stable defined as no hospitalizations for acute exacerbations, no changes in any antipsychotic medication within 3 months. 5. Subjects who are already receiving a stable regimen of paliperidone palmitate prolonged release suspension 100mg via the intramuscular route and have completed at least 2 maintenance doses prior to randomization. Note: For the subjects who will enter in to the lead-in period, the criteria will be evaluated during screening part II. 6. Acceptable hematology status: a. Hemoglobin greater than or equal to 9 g per dL b. Absolute neutrophil count (ANC) greater than or equal to 1500 cells per micro L c. Platelet count greater than or equal to 100,000 cells per micro L d. WBC count greater than or equal to 4000 cells per micro L 7. Acceptable liver function: a. Alanine aminotransferase less than or equal to 2.5 X upper limit of normal b. Aspartate aminotransferase (AST) less than or equal to 2.5 X ULN c. Bilirubin less than 1.5 mg per dL d. Alkaline phosphatase less than or equal to 2.5 X ULN 8. Subjects with creatinine clearance greater than or equal to 80 mL per minute (using the Cockcroft-Gault Equation). 9. Female subjects with negative serum pregnancy test at screening and negative urine pregnancy test before randomization. 10. Female subjects of childbearing potential (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during study participation) practicing two acceptable methods of contraception during the study. Acceptable methods of contraception are: a. Oral, parenteral, patch, or implant hormonal contraception b. Intrauterine device or intrauterine system c. Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent) d. Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject) e. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation f. Total abstinence, partial abstinence is not acceptable No history of addiction to any recreational drug or drug dependence or alcohol addiction.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients. 2. Subjects with history of or a current DSM-5-TR diagnosis of concurrent mental disorder besides schizophrenia (eg. schizoaffective-disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, dementia or mild neurocognitive disorder, and personality disorder). 3. Subjects with history of or have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening as per the Investigators discretion. 4. Subjects with history or presence of neuroleptic malignant syndrome (NMS) or tardive dyskinesia. 5. Subjects with history or presence of Parkinsons disease or epilepsy or seizures. 6. Subjects who are in an acutely agitated or severely psychotic state. 7. Elderly subjects with dementia-related psychosis treated with antipsychotic drugs. 8. Demonstration of repeated prolonged QTc interval (Bazetts formula (QTcB)) greater than 450ms in males and greater than 470ms in females, as measured on more than one ECG (either during screening, or from prior medical record) or presence of severe cardiovascular disease defined as having required cardiovascular surgery or the occurrence of incapacitating myocardial infarction within 12 months prior to screening. 9. Subjects with history of arrhythmia, venous thromboembolism, Intraoperative floppy iris syndrome. 10. Presence of orthostatic hypotension (ie. a drop in systolic blood pressure of 20 mmHg or more and/or a drop in diastolic blood pressure of 10 mmHg or more) within 3 minutes of standing from supine or history of syncope at screening. 11. Subjects with positive urine alcohol test. 12. Subjects with positive urine screen for drugs of abuse (including benzodiazepine, amphetamine, barbiturates, cannabinoid, cocaine, and morphine, except for benzodiazepine, which is a permissible medication if supported by prescription) 13. History or presence of any uncontrolled systemic disease (eg. cardiovascular disease, hypertension (systolic BP greater than or equal to 150 mmHg per diastolic BP greater than or equal to 100 mmHg), diabetes mellitus, (HbA1c greater than or equal to 9 percent at the time of screening), etc. 14. Smokers 15. Subjects with positive serology for Hepatitis B surface antigen and hepatitis B core antibody, Hepatitis C Virus or Human Immunodeficiency Virus. 16. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study that would limit adherence to study requirements. 17. Participation in any clinical study within 90 days before the first Investigational Product administration. 18. Loss of greater than or equal to 350 mL (1 unit) of blood within 90 days prior to first dose of Investigational Product. 19. Lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To achieve bioequivalence between both test and reference product by both primary and secondary PK endpoints. The primary PK endpoint is to demonstrate bioequivalence for the following steady state PK parameters: Maximum plasma concentration at steady state. AUC during a dosage interval at steady state. Concentration at the end of the dosing interval at steady state. Timepoint: Day 85,113,141(Pre Dose 00.00hrs),Day141,142,143,144,145,148, 151,154,157,160,163,166,169(Post Dose 06.00hrs,24.00hrs,48.00hrs,72.00hrs, 96.00hrs ,168.00hrs,240.00hrs,312.00hrs,384.00hrs,456.00hrs,528.00 hrs,600.00 hrs,672.00hrs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Average concentration during a dosing interval (Cavg,ss) Time until Cmax,ss is reached (Tmax,ss). Swing in steady state pharmacokinetics (Swing). Degree of fluctuation in the steady state pharmacokinetics (% Fluctuation). Minimum plasma concentration at steady state (Cmin,ss). Safety endpoint: To summarize safety data using descriptive statistics, of frequency/severity of, Adverse Events (AEs), of test product in comparison with the reference product.Timepoint: NA | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research
Outcome results
None listed