CTRI/2022/03/040709已完成未知
A randomized, multi-center, two-period, two-treatment, two-sequence, single dose, crossover, comparative bioavailability study of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial with Janssen’s Risperdal Consta®, 12.5 mg/vial in Twenty-four patients with Schizophrenia under fasting condition. - NA
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Patients having a clinical diagnosis of schizophrenia as per DSM V and on stabilized treatment with antipsychotic agents other than paliperidone or risperidone.
- •2.Patients with stable psychiatric symptoms as judged by the Investigator at the time of giving informed consent.
- •3.Patients with established tolerability to oral or injectable risperidone prior to dosing.
- •4.Male or non-pregnant, non-lactating female subjects
- •5.Patients must be between 18 and 65 years of age (inclusive)
排除标准
- •Exclusion Criteria
- •1.Patients who are on active treatment with drugs that are known to interact with risperidone
- •2.Diseases:
- •a. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies unless deemed not clinically significant by the Investigator.
- •b. Parkinson’s disease, mood disorders, or seizure disorder.
- •c. Patients with dementia related psychosis.
- •d. Patients with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
- •e. Patients with blood dyscrasias.
- •f. Glomerular Filtration Rate (GFR) less than 60 ml per min as estimated using the Cockcroft-Gault equation.
- •3.Oral Risperidone and/or paliperidone and Risperidone long-acting injection within 3 months prior to study drug administration. Paliperidone palmitate injection - 1 month and 3 month product within 1 year and 18 months respectively prior to study drug administration.
- •4.Patients with score of 2 in two or more movements or a score of 3 or 4 in a single movement as per AIMS (Abnormal Involuntary Movement Scale)
- •5.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, including: bradycardia, cardiac arrhythmias, hypokalaemia or hypomagnesemia, concomitant use of other drugs that known to prolong the QTc interval
- •6.Allergy or hypersensitivity to risperidone, paliperidone, other related products, or any inactive ingredients.
- •7.Patients with confirmed novel coronavirus infection (COVID-19)
研究者
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