CTRI/2020/10/028679进行中（未招募）未知
An open label, randomized, multiple dose, steady state, two-treatment, two-period, two-sequence, crossover, multi-center bioequivalence study of Risperidone Long acting Injection 25 mg/vial of Amneal EU, Limited and RISPERDAL CONSTA® (risperidone) long-acting injection 25 mg/vial of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in subjects with schizophrenia or bipolar I disorder. - NA
Dr Ilesh Changela0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subject or LAR willing and able to provide voluntary informed consent.
- •2. Male or female aged 18-65 years (both inclusive) at the time of consent.
- •3. Subjects having Body Mass Index (BMI) between 18.00 to 30.00 kg per m2
- •4. Subjects with diagnosis of Schizophrenia or bipolar I disorder as per DSM-V criteria
- •5. Subjects must be clinically stable, defined as no hospitalizations for
- •acute exacerbations, no changes in any antipsychotic medication within
- •3 months and CGI (s) scale lessthan 4 at pre-screening (Appendix c)
- •6. Acceptable hematology status:
- •a. Hemoglobin greater than or equal to 9 g per dL
- •b. Absolute neutrophil count greater than or equal to 1500 cells per microliter
- •c. Platelet count greater than or equal to 100,000 cells per microliter
- •7. Acceptable liver function:
- •a. Alanine aminotransferase less than or equal to 2X ULN
- •b. Aspartate aminotransferase less than or equal to 2X ULN
- •c. Bilirubin less than 1.2 mg per dL
- •d. Alkaline phosphatase less than or equal to 2X ULN
- •8. Subjects with Creatinine clearance greater than or equal to 60 mL per minute
- •9. Only for females of child bearing potential with negative serum pregnancy test
- •10. On a stable dose of Risperidone Long-acting intramuscular injection, 25 mg (Refer eligibility criteria of protocol synopsis) during randomization.
- •NOTE: The last injection, prior to entry into the Study Treatment Period, should be administered 14 days plus-or-minus 1 day prior to randomization.
- •11. Agree to receive intramuscular injections of Risperidone Long-acting intramuscular injection 25 mg for the entire duration of the study
- •12. Women of childbearing potential, defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product practicing any two acceptable methods of contraception.
- •Acceptable methods of contraception are:
- •a. Oral or other e.g. injection, patch or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
- •b. Intrauterine device or intrauterine system IUD or IUS
- •c. Double barrier method of contraception condom and occlusive cap or condom and spermicidal agent
- •d. Male sterilization at least 6 months prior to the 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.
- •13. Able to comply with study procedures in the opinion of the investigator.
排除标准
- •The subjects will be excluded from the study based on the following criteria:
- •1. Subjects with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the risperidone formulation
- •2. Subjects who are involuntarily-committed, uncooperative, or unwilling to sign consent form.
- •3. Subjects who are in an acutely agitated or severely psychotic state
- •4. History or presence of neuroleptic malignant syndrome, tardive dyskinesia, dementia-related psychosis, Parkinsons disease, thyrotoxicosis, hemorrhagic diathesis or epilepsy or seizures
- •5. Subjects who pose a significant risk of a suicide attempt based on history, investigators judgment or have answered yes on the questions 4 or 5 at Screening on Columbia Suicide Severity Rating Scale Appendix C
- •6. Current signs and symptoms of severe, progressive, or uncontrolled pulmonary, cardiac, gastrointestinal, hepatic, renal, genitourinary, hematological, endocrine, immunologic, or neurological disease
- •7. History of documented addiction or substance abuse within 6 months prior to study enrollment
- •8. Current or anticipated use of any of the prohibited medications during study participation of any of the prohibited medications Appendix A
- •9. Corrected QT interval Fridericias calculation greater than 450 m sec male or greater than 470 m sec female at screening or prior to administration of the 1st dose of IP, or with a known history of Torsades de Points, or family member with sudden unexplained cardiac death
- •10. History of cardiac disease which predispose to QT prolongation sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia or current medication of QT prolonging drugs
- •11. Subjects with uncontrolled diabetes mellitus
- •12. Significant orthostatic hypotension For Example, a drop in systolic blood pressure of 20 mm Hg or more and, or a drop in diastolic blood pressure of 10 mm Hg or more within 3 minutes of standing or history of syncope at pre-screening
- •13. Subjects with positive urine screen for drugs of abuse except for benzodiazepines which are permissible when supported by a prescription
- •14. Current surgical or other non-healing wounds or major surgical procedure including periodontal within 28 days of first study dose of IP or planned within 9 months
- •15. Subjects with positive serology for hepatitis B virus, 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 or that could limit adherence to study requirements
- •17. Participation in any clinical study within 90 days of first study dose of IP
- •18. Loss of greater than or equal to 350 mL 1 unit of blood within 90 days of first study dose of IP
- •19. Hyperprolactinemia greater than 200 mg per mL or less than 200 mg per mL with associated clinical symptoms
- •20. Lactating women
- •21. Any other significant disease, disorder or significant laboratory finding which, that in the opinion of the investigator, puts the subject at risk because of participation, impairs life expectancy, influences the result of the study, or affects the subjects ability to participate
- •22. If subject plan pregnancy during the course of the study and for three months thereafter
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