CTRI/2020/05/025244进行中（未招募）未知
A multicenter, open label, balanced, randomized, two-treatment, single-period, parallel, steady-state bioequivalence study of Paliperidone Palmitate injection 156mg/mL of Qilu Pharmaceuticals Co., Ltd. with INVEGA SUSTENNA® (Paliperidone Palmitate) ER Injectable Suspension 156mg/mL of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in subjects with schizophrenia. - NA
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
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.Subject aged 18-65 years (both inclusive) having body mass index (BMI) between 17.00 and 30.00 (both inclusive) calculated as weight in kg/height in m2.
- •3.Subjects with diagnosis of schizophrenia as per DSM-IV-TR criteria or later.
- •4.Subjects receiving Paliperidone long-acting injection at a dose of 156mg/mL via the intramuscular route and have completed at least 2 doses prior to randomization.
- •5.Acceptable hematology status:
- •a.Hemoglobin more than or equal to 9 g/dL
- •b.Absolute neutrophil count (ANC) more than or equal to 1500 cells / microlitre
- •c.Platelet count more than or equal to 100,000 cells/ microliter
- •6.Acceptable liver function:
- •a.Alanine aminotransferase (ALT) less than or equal to 2X upper limit of normal (ULN)
- •b.Aspartate aminotransferase (AST) less than or equal to 2X ULN
- •c.Bilirubin less than 1.2 mg/dL
- •d.Alkaline phosphatase less than or equal to 2X ULN
- •7.Subjects with creatinine clearance more than or equal 80 mL/minute.
- •8.Female subjects with negative serum pregnancy test at screening.
- •9.Females of child bearing potential must be willing to use adequate contraception (as defined below) throughout the study and continuing for at least 3 months after the last dose of the investigational product. For this study, acceptable and effective methods of contraception for females include:
- •a.Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period,
- •b.Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or
- •c.Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner).
- •10.For male subjects, one of the following must apply in order to avoid impregnating a female partner, from the first study dose and agree to follow throughout the study and for at least 3 months following the last dose of the study.
- •a.Absolute sexual abstinence (no sexual intercourse or genital contact with a female partner).
- •b.Use of barrier method with spermicide
- •11.No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •1.Hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients.
- •2.Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening.
- •3.History or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, dementia-related psychosis, Parkinsonâ??s disease or epilepsy/seizures.
- •4.Subjects on different antipsychotic treatment.
- •5.Subjects with congenital long QT syndrome.
- •6.Subjects with history of arrhythmia.
- •7.Subjects with positive urine screen for Drug of Abuse. (Except for benzodiazepine which is a permissible medication supported by prescription)
- •8.Uncontrolled clinically significant major cardiac, liver or kidney disease, diabetes mellitus etc.
- •9.Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
- •10.Any clinically significant abnormal laboratory parameter evaluated during screening.
- •11.Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •12.Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study that would limit adherence to study requirements.
- •13.Participation in any clinical study within 90 days before the first Investigational Product administration.
- •14.Donation and/or loss of more than or equal to 350 mL (1 unit) of blood within 90 days prior to first dose of Investigational Product for the current study.
- •15.Lactating women.
研究者
相似试验
已完成
不适用
A multicenter, open label, balanced, randomized, two-treatment, two- period, two-sequence, cross-over bioequivalence study of Pegylated Liposomal Doxorubicin HCl injection with that of Doxil® in ovarian cancer patients under fasting condition.CTRI/2014/08/004832Intas Pharmaceuticals Ltd48
已完成
不适用
Bioequivalence study of Risperidone in patients with schizophrenia or bipolar I disorder.CTRI/2018/09/015704Qilu Pharmaceutical Co Ltd24
进行中（未招募）
不适用
A multicenter, open label, balanced, randomized, two treatment, two-period crossover, multi-dose, steady state, bioequivalence study of Nevirapine 400 mg prolonged release tablets, compared to Viramune 400 mg prolonged release tablets in adult HIV1 infected patients.CTRI/2015/10/006244Amneal Pharmaceuticals Company GmbH
招募中
不适用
A multicenter, open label,patients with metastatic breast cancer patients under fed (standardized light meal) condition.CTRI/2022/06/043101TTY Biopharm Company Ltd
已完成
不适用
Bioequivalence study of Doxorubicin Hydrochloride Liposome Injection 20 mg/10mL of Dr. Reddyâ??s Laboratories, with that of Doxorubicin Hydrochloride Liposome Injection 20 mg/10mL of Sun Pharmaceutical Ind., in ovarian cancer patientsCTRI/2014/06/004703Dr Reddys Laboratories Limited60