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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- To evaluate the PK bioequivalence of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial with Janssen’s Risperdal Consta®, 12.5mg/vial in patients with schizophrenia under fasting conditions.
研究概览
简要总结
A bioequivalence study with Risperidone Long acting injection, 12.5mg/vial in subjects with schizophrenia with the following Objectives:
To evaluate the PK bioequivalence of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial with Janssen’s Risperdal Consta®, 12.5 mg/vial in patients with schizophrenia under fasting conditions.
To evaluate the safety and tolerability of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial in patients with schizophrenia.
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
- •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).
结局指标
主要结局
To evaluate the PK bioequivalence of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial with Janssen’s Risperdal Consta®, 12.5mg/vial in patients with schizophrenia under fasting conditions.
时间窗: In each period, patients will remain in the clinic from Day 1 (evening prior to | dosing) until Day 2 (24 hours after dosing) and PK samples will be collected on | Day 1 (pre-dose and at 1, 2, 4, 8, 12 hours) and on Day 2 (24 hours). | Patients will visit the site for ambulatory PK sample collection on Day 3, Day 5, Day 8, Day 11, Day 15, Day 18, Day 21, Day 24, Day 27, Day 30, Day 32, Day 34, Day 36, Day 38, Day 40, Day 43, Day 50, Day 57, and Day 64 in each period
Assessed after Period 1 dosing through to Day 64 of Period 1 and after Period 2 dosing through to Day 64 of Period 2
时间窗: In each period, patients will remain in the clinic from Day 1 (evening prior to | dosing) until Day 2 (24 hours after dosing) and PK samples will be collected on | Day 1 (pre-dose and at 1, 2, 4, 8, 12 hours) and on Day 2 (24 hours). | Patients will visit the site for ambulatory PK sample collection on Day 3, Day 5, Day 8, Day 11, Day 15, Day 18, Day 21, Day 24, Day 27, Day 30, Day 32, Day 34, Day 36, Day 38, Day 40, Day 43, Day 50, Day 57, and Day 64 in each period
次要结局
- TTo evaluate the safety and tolerability of Mylan’s Risperidone Long-Acting Injection, 12.5 mg/vial in patients with schizophrenia.(Safety will be assessed throughout the study i.e., from signing of ICF to end of study visit (Day 64 of period 2))