CTRI/2018/12/016671已完成未知
A Randomized, Multicenter, Multiple-dose, Crossover, Steady-state, Bioequivalence Study of Aripiprazole Extended Release Injectable Suspension and Abilify Maintena® in Subjects with Schizophrenia - NA
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- •Subjects must fulfill all the following inclusion criteria to be eligible for participation in the study:
- •1. Male or non-pregnant, non-lactating female subjects between 18 and 65 years of age (inclusive).
- •2. Documented diagnosis of schizophrenia
- •3. Subjects who are clinically stable and have had no hospitalization for exacerbation of psychiatric symptoms.
- •4. Currently stable on a regimen consisting of Aripiprazole Extended-Release Injectable Suspension
- •5. Subjects with established tolerability to oral Aripiprazole prior to screening
排除标准
- •Subjects must not be enrolled in the study if they meet any of the following criteria:
- •1. Known or suspected allergy or hypersensitivity to aripiprazole or other constituents of the formulation.
- •2. History of medically significant adverse events or intolerance with aripiprazole based on investigatorâ??s discretion.
- •3. Subjects who are on active treatment with drugs that are known to interact with Aripiprazole
- •4. Subjects with history or at risk of venous thromboembolism as per investigatorâ??s discretion.
- •5. Subjects with poor GFR on screening.
- •6. Subjects with Clinical Global Impression â?? Severity of illness (CGI-S) score of 5 or more.
- •7. Subjects with inadequate muscle mass to receive the intramuscular injection according to the investigator.
- •8. Subjects with a history of Neuroleptic Malignant Syndrome (NMS) or tardive dyskinesia while on treatment with atypical antipsychotics.
- •9. Subjects with dementia related psychosis.
- •10. Subjects with history or presence of seizures or other conditions that potentially lower the seizure threshold.
- •11. Presence of significant orthostatic hypotension
- •12. Subjects with known cardiovascular disease cerebrovascular disease, uncontrolled Hyperglycemia/diabetes mellitus,.
- •13. History of drug induced leukopenia/ neutropenia/ agranulocytosis.
- •14. Subjects with abnormal hematological parameters at screening and randomization
- •15. Subjects with abnormal liver function tests at screening and randomization
- •16. History of alcohol or substance abuse during the 6-month period immediately prior to screening.
- •17. Participation in any interventional clinical study within the past 90 days of randomization.
- •18. Male or female of childbearing potential unwilling to use adequate methods of contraception throughout the study.
- •19. History of difficulty with donating blood or difficulty in accessibility of veins.
- •20. Donation of blood within 90 days prior to receiving the first dose of investigational medicinal product in the study.
- •21. Subject who had major surgery within 4 weeks prior to study entry, who have not recovered from prior major surgery, or who have surgery scheduled during the course of the study.
- •22. Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg and/or HCV.
- •23. Subjects having any other clinically significant finding of the physical examination or laboratory value or any reason which, in the opinion of the investigator, would prevent the subject from safely participating in the study.
研究者
相似试验
已完成
3 期
The pharmacokinetic study of AryoSeven with Novoseven in Patients with Congenital Factor VII DeficiencyHereditary deficiency of factor VII.Hereditary deficiency of other clotting factorsD68.2IRCT2016120231193N1AryoGen Pharmed24
招募中
3 期
Study To Test The Usage of Denosumab In Patients with Cancer spread to BoneCTRI/2022/05/042823Hetero Biopharma Limited
尚未招募
3 期
Study to know the usefulness of Trastuzumab Emtansine medicine in widespread breast cancer patientsCTRI/2019/08/020544Hetero Biopharma Limited
已完成
3 期
A Clinical Study to verify its use and side effects profile of Hetero Trastuzumab in Patients of late stage breast cancerCTRI/2019/03/018009Hetero Biopharma Limited191
招募中
不适用
To assess blood concentration of Paliperidone Prolonged Release Injectable Suspension at different times in patients with Schizophrenia following multiple dosesCTRI/2021/12/038455Mylan Laboratories Limited216