CTRI/2021/12/038455招募中未知
A Randomized, Multicenter, Multiple-dose, Two-treatment, Single period,Parallel, Steady-State Bioequivalence Study of Mylanâ??s Paliperidone Prolonged-Release Injectable Suspension 100 mg and Xeplion® 100 mg of Janssen-Cilag Ltd in Subjects with Schizophrenia under Fasting Condition
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 216
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
- •Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- •1. Male or non-pregnant, non-lactating female subjects between 18 and 65 years of age (both inclusive)
- •2. Patients having a clinical diagnosis of schizophrenia as per DSM V.
- •3. Patients with established tolerability and responsiveness to oral paliperidone/risperidone or injectable paliperidone prior to screening
- •4. Subjects who are on a stable regimen of 100 mg one-month paliperidone prolonged-release suspension for injection (e.g. Xeplion® 100 mg)
- •5. Subjects who are clinically stable with no hospitalizations for exacerbation of psychiatric symptoms
- •6. Weight: Each subject is required to weigh at least 50 kg (110 lbs) for men and 48 kg (106 lbs) for women and have a Body Mass Index (BMI) value less than or equal to 35.0 kg/m2 but greater than or equal to 18.0 kg/m2.
排除标准
- •Exclusion Criteria:
- •Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- •1. Institutionalized subjects.
- •2. Subjects with history of alcohol or drug-dependence as per DSM-V criteria.
- •3. Subjects with Ingestion of any alcoholic beverage within the 24 hours prior to the initial administration of study medication.
- •4. Subjects with ingestion of risperidone long-acting injection
- •5. Subjects with depot injection or implant of any drug other than hormonal contraceptive or hormone replacement therapy
- •6. Subjects currently being treated with Clozapine, monoamine oxidase inhibitor (MAOI) antidepressants, electroconvulsive therapy
- •7. Use of any medication, herbal supplement, or vitamin known to induce or inhibit hepatic enzyme activity
- •8. Subjects with dementia related psychosis
- •9. Subjects with Clinical Global Impression - Severity of illness (CGI-S) score of 5 or more
- •10. Subjects with suicidal ideation
- •11. Subjects with a history of Neuroleptic Malignant Syndrome (NMS)
- •12. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease, uncontrolled metabolic diseases, clinically significant laboratory results or malignancies by the Principal Investigator or Medical Sub-Investigator.
- •13. Use of drugs that prolong the QTc interval,
- •14. Subjects with positive HIV, hepatitis B antigen, hepatitis C antibody, RPR or VDRL test
- •15. Subjects with positive urine drug screen
- •16. Subjects with history or presence of tardive dyskinesia, seizures idiopathic Parkinsonâ??s disease, cognitive and motor impairment.
- •17. Subjects with donation or loss of blood or plasma
- •18. Subjects with participation in any interventional clinical study
- •19. Subjects with allergy or hypersensitivity to paliperidone, risperidone, other related products, or any inactive ingredients
- •20. Subjects has clinical signs and symptoms consistent with COVID-19 or had severe COVID-19
研究者
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