CTRI/2023/04/051845已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 12
- 主要终点
- To evaluate the bioequivalence 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
研究概览
简要总结
A bioequivalence study with Risperidone Long Acting Injection 25 mg in patients with Schizophrenia or Bipolar I Disorder following objectives:
To evaluate the bioequivalence 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.
To evaluate the safety and tolerability of Mylan’s Risperidone Long Acting Injection 25 mg/vial in subjects with schizophrenia or bipolar I disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise
- •Male or non-pregnant, non-lactating female between 18 and 65 years of age.
- •Subjects with BMI 18 to 35 kg/m2
- •Diagnosed with schizophrenia or Bipolar I disorder as per DSM-V criteria
- •Subjects with stable psychiatric symptoms
- •Currently stable on a regimen consisting of risperidone long-acting injection
- •Subjects with Clinical Global Impression.
- •Severity of illness (CGI-S) score less than or equal to 4
- •Subjects with adequate hematological parameters
- •Subjects with adequate hepatic function
- •Subjects with Negative HIV, hepatitis B antigen, hepatitis C antibody, RPR or VDRL test
- •Subjects with negative urine drug screen
- •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:
- •Subjects with Known or suspected allergy or hypersensitivity to risperidone, paliperidone or similar drugs.
- •Diagnosis of alcohol or substance abuse during the 6-month period.
- •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.
- •History of uncontrolled diabetes, significant orthostatic hypotension uncontrolled hypertension, Parkinson’s disease, mood disorders or seizure disorder.
- •Subjects with dementia related psychosis.
- •Hospitalization due to exacerbation of psychiatric symptoms
- •Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
- •Subjects with blood dyscrasias.
- •Received Electroconvulsive Therapy (ECT)
- •Subjects with suicidal ideation score of 4 or 5 on Columbia Suicidal Severity Rating Scale.
- •Subjects who are on active treatment with drugs that are known to interact with risperidone.
- •History of neuroleptic malignant syndrome or tardive dyskinesia.
- •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
- •Male or female of childbearing potential unwilling to use adequate method of contraceptive precautions throughout the study.
- •Any food allergy, intolerance, restriction or special diet
- •Participation in any interventional clinical study
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •Donation of blood.
结局指标
主要结局
To evaluate the bioequivalence 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
时间窗: After 5th dose of period I and 3rd and 5th Dose of period II
次要结局
- To evaluate the safety and tolerability of Mylan’s Risperidone Long Acting Injection 25 mg/vial in subjects with schizophrenia or bipolar I disorder.(Safety will be assessed throughout the study,)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Risperidone Long acting injection in patients with Schizophrenia.Schizophrenia, unspecified,CTRI/2022/03/040709Mylan Laboratories Limited24
Unknown
不适用
A study to compare drug levels in blood of two formulations of a long acting injection of the drug Risperidone after administration in patients with SchizophreniaSchizophreniaCTRI/2018/09/015774Mylan Laboratories Limited88
招募中
不适用
Study to prove bioequivalence of Risperidone prolonged-release susp. for Intra Muscular inj 25 mg/vial of Pharmathen S.A. Greece in adult schizophrenic patients who are on stable dose.SchizophreniaCTRI/2018/01/011521Pharmathen S A100
已完成
不适用
Pharmacokinetic study of paliperidone palmitate in patients with schizophrenia.Schizophrenia, unspecified,CTRI/2018/08/015469Mylan Laboratories Limited264
已完成
不适用
Pharmocokinetic Study of Aripiprazole Extended Release Injectable Suspension in patients with SchizophreniaSchizophrenia, unspecified,CTRI/2018/12/016671Mylan Laboratories Limited88