CTRI/2019/06/019553尚未招募未知
An Open Label, Randomized, Multiple Dose, Steady State, Two-Treatment, Two Period, Two-Sequence, Crossover, Multi-Center Bioequivalence Study of Risperidone for Injectable Suspension 25 mg/Vial manufactured by Amneal Pharmaceuticals Pvt. Ltd. for PharmaSophia, LLC and RISPERDAL CONSTA® (risperidone) Long-Acting Injection 25 mg/Vial Manufactured for JANSSEN Division of ORTHO-MCNEIL-JANSSEN PHARMACEUTICAL INC., Titusville, NJ 08560 in Patients of Schizophrenia or Bipolar I disorder. - CBCC/2018/021
PharmaSophia LLC0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Willing and able to provide voluntary informed consent and to follow the protocol requirements.
- •2.Male or female aged 18-65 years (both inclusive) at the time of dosing.
- •3.Patients having Body Mass Index (BMI) between 18.50 and 30.00 kg/m2 (both inclusive).
- •4.Patients with diagnosis of Schizophrenia or Bipolar I Disorder as per DSM-V criteria for at least 3 months before screening.
- •5.Patients will be from any one of the following treatment groups:
- •Already receiving a stable dose of 25 mg risperidone long-acting injection every two weeks for a minimum of 2 months prior to randomization.
- •Subjects on other Risperidone formulations who are receiving daily 2 mg of oral risperidone that can be continued for 21 days after the first injection of RISPERDAL CONSTA® (US RLD).
- •Subjects who have never taken any oral Risperidone and are able to tolerate at least 0.5 mg or 1 mg of oral Risperidone as recommended by the physician.
- •6.Acceptable hematology status:
- •a.Hemoglobin >= 9 g/dL
- •b.Absolute neutrophil count (ANC) >= 1500 cells/µL
- •c.Platelet count >= 100,000 cells/µL
- •7.Acceptable liver function:
- •a.Alanine aminotransferase (ALT) <= 2X ULN
- •b.Aspartate aminotransferase (AST) <= 2X ULN
- •c.Bilirubin < 1.2 mg/dL
- •d.Alkaline phosphatase <= 2X ULN
- •8.Patients with Creatinine clearance >= 60 mL/minute
- •9.No clinically significant illness other than Schizophrenia or Bipolar I Disorder.
- •10.If female of child bearing potential (who has not completed 1 year after menopause & have not gone through hysterectomy or bilateral tubal ligation), a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening.
- •11.Use of a highly effective method of birth control (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or surgically sterile or post-menopausal [at least 12 months prior to Study drug administration]) during the study and for ninety (90) days thereafter for women of child-bearing potential.
- •12.Able to comply with study procedures in the opinion of the investigator.
排除标准
- •1.History of allergy to Paliperidone or Risperidone or any of the components of the formulation.
- •2.Exacerbation of Schizophrenia or Bipolar I Disorder requiring hospitalization within the past two (2) months prior to screening and during the screening period.
- •3.Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, moderately severe or severe extra-pyramidal symptoms, Parkinsons disease, neuroleptics malignant syndrome, epilepsy or seizure disorder.
- •4.Current or relevant history of serious, severe or unstable psychiatric illness except Schizophrenia or Bipolar I Disorder.
- •5.Current or relevant history of alcohol or drug dependence within the past six (6) months prior to screening.
- •6.Positive testing for the drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, morphine, marijuana) done by urine scan or breath alcohol test at Day 1. (Except for benzodiazepine which is a permissible medication supported by prescription).
- •7.Subjects with significant risk of suicidal, homicidal, or violent ideation or behavior (as clinically assessed by the investigator).
- •8.Uncontrolled arterial hypertension with systolic blood pressure >180 mm Hg and diastolic pressure >100 mm Hg at screening.
- •9.Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing) or history of syncope at screening.
- •10.Current or relevant history of myocardial infarction or unstable angina within the 3 months prior to screening.
- •11.QTc >500 msec in male subject or QTc > 470 msec in female subjects at screening.
- •12.Current or relevant history of untreated life-threatening ventricular arrhythmias.
- •13.Current history of uncontrolled diabetes mellitus at screening.
- •14.Current or relevant history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic).
- •15.Current or relevant history of cataracts.
- •16.Current malignancy or history of malignancy that has not been in remission for more than five (5) years, except effectively treated basal cell skin carcinoma.
- •17.Planned elective surgery or other procedures requiring general anesthesia during the study.
- •18.Current signs and symptoms of significant medical disorders other than listed above such as severe, progressive, or uncontrolled pulmonary, cardiac, gastrointestinal, hepatic, renal, genitourinary, hematological, endocrine, immunologic, or neurological disease.
- •19.Any other significant disease, disorder or significant laboratory finding which, that in the opinion of the investigator, puts the subject at risk because of participation, impairs life expectancy, influences the result of the study, or affects the subjects ability to participate.
- •20.A medical or surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the drug.
- •21.A positive screening test for HIV, hepatitis B surface antigen or HCV antibodies.
- •22.Donation and/or loss of 350 mL (1 unit) of blood within 90 days prior to first dose of Investigational Product for the current study.
- •23.Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables including CYP2D6 inhibitors or inducers
研究者
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