CTRI/2021/03/031752已完成未知
Open-Label, Randomized, Multiple-Dose, Two-Treatment, Reference-Replicate, Crossover, Steady State Relative Bioavailability Study of Lupin Risperidone Long-Acting Injection Compared with Risperdal Consta�® (Risperidone) Long-Acting Injection in Adult Male and Female Patients with Schizophrenia
anomi BV a Lupin group company0 个研究点目标入组 94 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 94
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. Willing to participate in the study; capable of reading, understanding, and providing voluntary written study specific informed consent in the designated language of the study site, and willing to comply with the study restrictions. The patientââ?¬•s legally authorized representative should review the information and sign the informed consent in case the patient has impaired cognitive function judged by the Investigator.
- •2. Male or female 18 to 65 years of age (inclusive) at the Screening visit.
- •3. Body Mass Index (BMI) 18.0ââ?¬â??35.0 kg/m2 (inclusive) at the Screening visit.
- •4. Chronic Schizophrenia as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
- •5. Stable disease, as evidenced by a Clinical Global Impression-Severity scale (CGI-S) score ââ?°Â¤4.
- •6. For the Screening visit, the patient should be receiving a stable regimen of risperidone long-acting IM injection
- •7. Female patients of: ââ?¬Â¢childbearing potential, use adequate contraception:
排除标准
- •Patients must not be enrolled in the study if they meet any of the following criteria:
- •1. Females who are pregnant, lactating, or planning to attempt to become pregnant.
- •2. Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant.
- •3. Hospitalization for a psychotic episode within 6 months prior to the first dose of study medication.
- •4. Use of any antipsychotic medications during the specified restriction periods.
- •5. Clinically significant clinical laboratory abnormality, ECG, or other clinical findings on physical or neurological examination indicative of a clinically significant exclusionary disease).
- •6. History or current evidence of thrombotic or thromboembolism disorders, or have received anticoagulant or antithrombotic treatment
- •7. Fridericia-corrected QT interval (QTcF) >450 msec for males and >470 msec for females, or other clinically significant ECG findings (in the opinion of the Investigator or designee).
- •8. History of malignancy within the past five years except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- •9. History or current evidence of clinically relevant cardiac arrhythmia, cardiovascular disease, uncontrolled hypertension, thyrotoxicosis, uncontrolled hypoactive thyroid disease (), parkinsonism, or hemorrhagic diathesis.
- •10. Posed a significant risk of a suicide attempt or violent behavior
- •11. Uncontrolled diabetes mellitus,; or Type 2 diabetes newly diagnosed during the screening period.
- •12. History of, or currently diagnosed with a convulsion disorder.
- •13. Electroconvulsive therapy within 2 months prior to the Screening visit.
- •14. Clinically significant laboratory value for white blood cell count ââ?°Â¤3 Ã?â?? 103 /Ã?¼L or an absolute neutrophil count ââ?°Â¤1.3 Ã?â?? 103 /Ã?¼L, or hemoglobin.
- •16. History of hypersensitivity or intolerance to risperidone), paliperidone, or any compound listed as being present in the study formulation.
- •17. History of Neuroleptic Malignant Syndrome, significant tardive dyskinesia, severe akathisia, or extra-pyramidal reactions such as dystonia
- •18. Positive hepatitis).
- •19. Positive test result for human immunodeficiency virus (HIV) antibody).
- •20. Positive results from screens for alcohol or substances of abuse .
- •21. Meet DSM-V criteria for moderate to severe alcohol use disorder.
- •22. Meet DSM-V criteria for moderate or severe substance use disorder.
- •23. History of difficulty with phlebotomy.
- •24. Donation of blood (1 pint or more) or plasma within 30 days prior to receiving the first dose of study medication.
- •25. Use of an investigational drug or product, or participation in a drug research study within 30 days prior to receiving the first dose of study medication, or 5 times the half-life of the investigational drug, whichever is longer.
- •26. Any condition which (in the opinion of the Investigator) would interfere with the patientââ?¬•s ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the patient if he or she took part in the trial.
- •27. Use of a strong inducer of CYP3A4.
- •28. Use of a strong inhibitor of CYP3A4 or CYP2D6.
- •29. Use of a monoamine oxidase inhi
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