CTRI/2018/09/015774Other不适用
A Randomized, Open Label, Two-Period, Two-Treatment, Two-Sequence, Multiple Dose, Crossover, Multicenter, Steady State Bioequivalence Study of Risperidone Long Acting Injection 25 mg/vial of Mylan Laboratories Limited, India with RISPERDAL CONSTA® (Risperidone) 25 mg/vial of Janssen Pharmaceuticals, Inc., USA in Subjects with Schizophrenia under Fasting Condition.
适应症
试验速览
- 阶段
- 不适用
- 状态
- Other
- 入组人数
- 88
- 试验地点
- 10
- 主要终点
- To evaluate the bioequivalence of risperidone long acting injection 25 mg/vial of Mylan Laboratories Limited, India with RISPERDAL CONSTA®(risperidone) 25 mg/vial of Janssen Pharmaceuticals, Inc., USA in subjects with schizophrenia.
研究概览
简要总结
A bioequivalence study with risperidone in subjects with schizophrenia..
This study includes:
Screening period: Male and non-pregnant female subjects with schizophrenia will be eligible for the screening procedure. A written informed consent will be obtained prior to initiating screening procedures.
Treatment period: Subjects will be randomized to receive either Mylan’s Risperidone Long Acting Injection 25 mg/vial or Janssen’s RISPERDAL CONSTA® (Risperidone) 25 mg/vial as intramuscular injection as per randomization schedule (either the test or reference product) in a crossover design. Subject will receive each product in a cross-over fashion Subject will be randomized in a 1:1 ratio to one of the 2 sequences (TR or RT).
Main conclusion on the bioequivalence will be drawn based on the PK data obtained during last dosing interval. Plasma concentrations of risperidone will be measured by a using validated method at Mylan Laboratories Limited.
Statistical analysis of pharmacokinetic parameters comparing test and reference products will be performed to assess bioequivalence.
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
- •Male or non-pregnant, non-lactating female between 18 and 65 years of age (inclusive).
- •Diagnosed with schizophrenia Subjects with stable psychiatric symptoms as judged by the investigator/sub-investigator at the time of giving informed consent.
- •Currently stable on a regimen consisting of risperidone long-acting injection as judged by the Principal investigator/Medical Sub-investigator prior to randomization.
- •Subjects with adequate renal function defined as creatinine clearance (Cockcroft-Gault Equation) more than or equal to 80 mL/min Adequate hematological parameters at screening and randomization Adequate hepatic function at screening and randomization The subject and LAR must demonstrate adequate decision-making ability in order to make an informed choice about participating in this study by providing written informed consent.
- •Agree to comply with the visit schedule and other requirements of the study.
排除标准
- •Known or suspected allergy or hypersensitivity to risperidone, paliperidone or similar drugs or other constituents of the formulation. Diagnosis of alcohol or substance abuse as per DSM-V criteria during the 6-month period immediately prior to screening. Any changes in antipsychotic medication or dosage during the past eight weeks prior to the first dose in Study Period I. Relevant 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 during the 3 months before screening. Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor. Subjects with blood dyscrasias. Received Electroconvulsive Therapy (ECT) within the last 3months prior to screening. Subjects with Clinical Global Impression.
- •Severity of illness (CGI-S) score of 5 or more. Any acute unstable or significant concomitant medical illness. Subjects who are on active treatment with drugs that are known to interact with risperidone. History of neuroleptic malignant syndrome or tardive dyskinesia. Attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior as clinically assessed by the investigator. 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 Subjects who are: • Pregnant. • Breast feeding • Male or female of childbearing potential unwilling to use adequate method of contraceptive precautions throughout the study. • Subject whom had major surgery within 4 weeks prior to study entry, who have not recovered from prior major surgery, or whom have surgery scheduled during the course of the study. • Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV Subjects with clinically significant laboratory investigations as per the investigator’s judgment. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the subject’s participation in this study. Participation in any interventional clinical study within the past 90 days prior to study entry. History of difficulty with donating blood or difficulty in accessibility of veins. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study. Any reason which, in the opinion of the Principal Investigator or Co-Investigator, would prevent the subject from safely participating in the study.
结局指标
主要结局
To evaluate the bioequivalence of risperidone long acting injection 25 mg/vial of Mylan Laboratories Limited, India with RISPERDAL CONSTA®(risperidone) 25 mg/vial of Janssen Pharmaceuticals, Inc., USA in subjects with schizophrenia.
时间窗: Not Applicable
次要结局
- To evaluate the safety and tolerability of risperidone long acting injection 25 mg/vial of Mylan Laboratories Limited, India in subjects with schizophrenia.(Safety will be evaluated throughout the study starting from the signing of informed consent form and till 28 (± 2) days after the last sample collection (Safety follow-up).)
研究者
研究点 (10)
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