CTRI/2023/09/058099进行中（未招募）Unknown
A Randomized, Multicenter, Open-Label, Two-Treatment, Two-Period, Two-Sequence, Multiple-Dose, Steady-State, Crossover Bioequivalence Study of Paliperidone 100 mg Prolonged Release Suspension for Injection of Sun Pharmaceutical Industries Limited, India with Xeplion (Paliperidone) 100 mg Prolonged Release Suspension for Injection of Janssen-Cilag International NV, Belgium in Patients with Schizophrenia - NI
试验速览
- 阶段
- Unknown
- 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. Male or female patient between age of 18 and 65 years both inclusive with body mass index BMI greater than or equal to 18.00 kg per m2 and 50 kg weight for male patient and 48 kg for female patient
- •2. Patient and LAR must demonstrate adequate decision-making ability to make an informed decision about participating in this study by providing a written informed consent
- •3. Patient with documented diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders Fifth Edition DSM V or latest version criteria refer Appendix I
- •4. Patients who are clinically stable and not hospitalized for exacerbation of psychiatric symptoms during 3 months before screening and till randomization
- •5. Patients who are receiving Paliperidone 100 mg prolonged release suspension for injection at a dose 100mg per mL via the intramuscular route and have completed at least two maintenance doses prior to randomization or patients on a stable dose of risperidone long-acting injection 50mg dose administered every 2 weeks consecutively for at least 6 doses
- •NOTE For the patients who will enter in to the stabilisation period, the criteria will be evaluated during screening part II
- •6. Acceptable hematology status
- •a. Hemoglobin greater than or equal to 9 g per dL
- •b. Absolute neutrophil count ANC greater than or equal to 1500 cells per microlitre
- •c. Platelet count greater than or equal to 100000 cells per microlitre
- •7. Acceptable liver function
- •a. Alanine aminotransferase ALT less than 5.0 times upper limit of normal ULN
- •b. Aspartate aminotransferase AST less than 5.0 times ULN
- •c. Total bilirubin less than 1.5 mg per dL
- •d. Alkaline phosphatase less 5.0 times ULN
- •8. Patients with creatinine clearance greater than or equal to 80 mL per minute calculated using the Cockcroft-Gault equation
- •9. Non-smokers
- •10. Female patients must be post-menopausal at least 1 year or surgically sterile or are ready to use an effective method of birth control Female of childbearing potential must have a negative serum pregnancy test at the screening visit
- •11. Male patients must agree to use a barrier method of contraception for the duration of the study if sexually active with a female of childbearing potential Method of contraception should remain same throughout the study
- •12. Patients with no history of addiction to any recreational drug or drug dependence or alcohol addiction
- •13. Patient having good general health and free of any disease state or physical condition that might impair evaluation of Schizophrenia
- •14. Free of exposure to any unacceptable risk by study participation as per investigator opinion
排除标准
- •1. Patient who is pregnant lactating or planning to become pregnant during the study
- •2. Patient with signs and symptoms suggesting of COVID 19 infection
- •3. Known hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients of IP or to any other similar class of drugs
- •4. Patient having current thoughts of suicide that is suicidal ideation or violent tendencies at the time of screening as per investigators discretion
- •5. Patient with history or presence of neuroleptic malignant syndrome NMS or tardive dyskinesia dementia related psychosis Parkinsons disease or epilepsy or seizures or cognitive and motor impairment
- •6. Patient with history of arrhythmia
- •7. Patient with positive urine screen for drugs of abuse except for benzodiazepine which is a permissible medication supported by written prescription
- •8. Patient with positive urine alcohol test
- •9. Patient with history or current signs and symptoms of severe progressive or uncontrolled pulmonary cardiac gastrointestinal hepatic renal genitourinary hematological endocrine immunologic metabolic or neurological disease
- •10. Patient with a corrected QT interval by Bazetts formula QTcB greater than 450 msec for male or greater than 470 msec for female at screening or prior to administration of the first dose of IP or with a known history of Torsades de Points or any family member with sudden unexplained cardiac death
- •11. History of cardiac disease which predispose to QT prolongation like sick sinus complete AV block CHF ventricular tachycardia hypokalemia or hypocalcemia or history of taking drugs that prolong QT
- •12. Presence of significant orthostatic hypotension that is decrease in systolic blood pressure greater than equal to 20 mmHg or diastolic BP of greater than equal to 10 mmHg when comparing standing to supine values or uncontrolled hypertension that is systolic BP greater than or equal to 150 mmHg or diastolic BP greater than or equal to 100 mmHg or history of syncope at screening
- •13. Current or anticipated use of any of the prohibited medications during study participation
- •14. Patient with skin abnormalities or irritations at the potential injection site that is right or left gluteal or deltoid muscle as determined by the investigator
- •15. Patient with any other medical condition or serious intercurrent illness that in the opinion of the investigator may make it undesirable for the patient to participate in the study that would limit adherence to study requirements
- •16. Patient who had major surgery within 28 days prior to receiving the first dose of IP who have not recovered from prior major surgery or who have surgery scheduled during the course of the study
- •17. Patient with known positivity for human immunodeficiency virus HIV HbsAg and or HCV
- •18. Participation in any interventional clinical study within the past 90 days of randomization.
- •19. Donation of blood that is 1 unit or 350 ml within 90 days prior to receiving the first dose of IP in the study
- •20. Patient 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 patient from safely participating in the study
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