CTRI/2023/04/051845已完成Unknown
Multicenter, Randomized, Two-Period, Two-Treatment, Two-Sequence, Multiple Dose, Steady-state, Crossover, Comparative Bioavailability Study of Mylan’s Risperidone Long Acting Injection 25 mg/vial with Janssen’s Risperdal Consta® 25 mg/vial in Subjects with Schizophrenia or Bipolar I disorder under Fasting Conditions
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 159
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
- •Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise
- •1. Male or non-pregnant, non-lactating female between 18 and 65 years of age.
- •2. Subjects with BMI 18 to 35 kg/m2
- •3. Diagnosed with schizophrenia or Bipolar I disorder as per DSM-V criteria
- •4. Subjects with stable psychiatric symptoms
- •5. Currently stable on a regimen consisting of risperidone long-acting injection
- •6. Subjects with Clinical Global Impression - Severity of illness (CGI-S) score less than or equal to 4
- •7. Subjects with adequate hematological parameters
- •8. Subjects with adequate hepatic function
- •9. Subjects with Negative HIV, hepatitis B antigen, hepatitis C antibody, RPR or VDRL test
- •10. Subjects with negative urine drug screen
- •11. Subjects with negative X-ray for tuberculosis
排除标准
- •Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- •1. Subjects with Known or suspected allergy or hypersensitivity to risperidone, paliperidone or similar drugs.
- •2. Diagnosis of alcohol or substance abuse during the 6-month period.
- •3. History or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease, organic mental disorder), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease.
- •4. History of uncontrolled diabetes, significant orthostatic hypotension uncontrolled hypertension, Parkinson’s disease, mood disorders or seizure disorder.
- •5. Subjects with dementia related psychosis.
- •6. Hospitalization due to exacerbation of psychiatric symptoms
- •7. Subjects with renal function abnormality.
- •8. Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
- •9. Subjects with blood dyscrasias.
- •10. Received Electroconvulsive Therapy (ECT)
- •11. Subjects with suicidal ideation score of 4 or 5 on Columbia Suicidal Severity Rating Scale.
- •12. Subjects who are on active treatment with drugs that are known to interact with risperidone.
- •13. History of neuroleptic malignant syndrome or tardive dyskinesia.
- •14. History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval
- •15. Male or female of childbearing potential unwilling to use adequate method of contraceptive precautions throughout the study.
- •16. Subjects with clinically significant laboratory investigations as per the investigator’s judgment.
- •17. Any food allergy, intolerance, restriction or special diet
- •18. Participation in any interventional clinical study
- •19. History of difficulty with donating blood or difficulty in accessibility of veins.
- •20. Donation of blood
研究者
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