【ChiCTR1800018599】Bioequivalence study of Risperidone in patients with schizophrenia or bipolar I disorder

ChiCTR1800018599

尚未开始

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2018-09-26

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精神分裂症或双极性I型障碍

Bioequivalence study of Risperidone in patients with schizophrenia or bipolar I disorder

Bioequivalence study of Risperidone in patients with schizophrenia or bipolar I disorder

382210

Primary Objective: To assess the steady-state bioequivalence of Risperidone Long-acting intramuscular injection of Qilu Pharmaceuticals Co. Ltd. with RISPERDAL CONSTA? (Risperidone) LONG-ACTING INJECTION of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in patients with schizophrenia or bipolar I disorder who are already receiving a stable regimen of Risperidone long-acting injection via the intramuscular route. Secondary Objective: To monitor the adverse events and to ensure the safety of Patients.

随机交叉对照

探索性研究/预试验

Computer Generated Randomization

未说明

齐鲁制药有限公司

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12

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2018-03-27

2019-07-17

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The patients will be considered eligible for the study based on the following criteria: 1. Willing and able to provide voluntary informed consent and to follow the protocol requirements; 2. Patient aged 18-65 years (both inclusive) having Body Mass Index (BMI) between 17.00 and 30.00 (both inclusive) calculated as weight in kg/height in m2; 3. Patients with diagnosis of Schizophrenia or Bipolar I Disorder as per DSM-IV-TR criteria or later; 4. Patients receiving Risperidone long-acting injection at a dose of 25mg/vial via the intramuscular route and have completed at least 2 doses prior to randomization; 5. Acceptable hematology status: (1) Hemoglobin ≥ 9 g/dL; (2) Absolute neutrophil count (ANC) ≥ 1500 cells/μL; (3) Platelet count ≥ 100,000 cells/μL; 6. Acceptable liver function: (1) Alanine aminotransferase (ALT) ≤ 2X upper limit of normal (ULN); (2) Aspartate aminotransferase (AST) ≤ 2X ULN; (3) Bilirubin < 1.2 mg/dL; (4) Alkaline phosphatase ≤ 2X ULN; 7. Patients with Creatinine clearance ≥ 60 mL/minute; 8. Female patients with negative urine pregnancy test on admission day and serum pregnancy test at screening; 9. Females of child bearing potential must be willing to use adequate contraception (as defined below) throughout the study and continuing for at least 3 months after the last dose of the investigational product. For this study, acceptable and effective methods of contraception for females include: (1) Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period; (2) Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom); or (3) Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner). 10. For male patients, one of the following must apply in order to avoid impregnating a female partner, from the first study dose and agree to follow throughout the study and for at least 3 months following the last dose of the study: (1) Absolute sexual abstinence (no sexual intercourse or genital contact with a female partner); (2) Use of barrier method with spermicide; 11. No history of addiction to any recreational drug or drug dependence or alcohol addiction.；

The patients will be excluded from the study based on the following criteria: 1. Hypersensitivity to Risperidone or Paliperidone or to any of the excipients; 2. Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening; 3. History or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, dementia-related psychosis, Parkinsons disease or epilepsy/seizures; 4. Patients with positive urine screen for Drug of Abuse; 5. Patients who are on active treatment with drugs that are known to interact with risperidone (such as Strong CYP2D6 inhibitors, CYP3A4 enzyme inducers); 6. Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day; 7. Patients on different antipsychotic treatment; 8. Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product; 9. Surgical or other non-healing wounds; 10. Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV); 11. Uncontrolled diabetes mellitus; 12. An unusual or abnormal diet, for whatever reason planned e.g. religious fasting during the course of the study. 13. 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; 14. Participation in any clinical study within 90 days before the first dose of Investigational Product; 15. Donation and/or loss of 350 mL (1 unit) of blood within 90 days prior to first dose of Investigational Product for the current study; 16. Patient is currently Pregnant or breastfeeding.；

齐鲁制药有限公司/印度CBCC全球临床研究合同组织

382210