CTRI/2019/01/016865尚未招募未知
A randomized, open label, multicenter, parallel group, multiple dose, steady state study to compare the bioavailability and characterize the pharmacokinetic profile of the sponsorâ??s test formulation [Paliperidone Palmitate extended release injectable suspension, (156 mg/ml)] relative to that of the reference formulation [Invega® Sustenna® (Paliperidone Palmitate extended release injectable suspension, 156 mg/ml), Janssen Pharmaceuticals, Inc., Titusville, New Jersey] and establish bioequivalence in patients of Schizophrenia already receiving a stable regimen of paliperidone palmitate extended release injectable suspension.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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. Written informed consent for participation in the study by the patient and patientâ??s legal acceptable representative (LAR).
- •2. Schizophrenic male or female patients, between 18 and 75 years of age (both inclusive)
- •3. Patients having BMI between 18-35 kg per meter square (up to 2 percentage deviation is acceptable) and at least 50 kg weight for male patients and 48 kg for female patients.
- •4. Patients who are stabilized on 156 mg dose of paliperidone palmitate extended release injectable suspension once every month (atleast 3 doses prior to randomization) would be eligible to participate in the study by continuing their established maintenance dose.
- •5. Patients have a documented clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition
- •6. Patients having Clinical Global Impression scale score of less than or equal to 4 at both screening and Baseline.
- •7. Patients not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening, medical history, physical examination, 12-lead ECG recordings and Chest X-ray.
- •8. Adequate hematological parameters at screening and randomization
- •9. Adequate hepatic function at screening and randomization
- •10. Patients able to comply with study procedures in the opinion of the investigator.
- •11. In case of Male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
- •12. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (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 sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician
排除标准
- •1. Patients with current or relevant history of psychiatric illness except schizophrenia.
- •2. Patients with clinically significant illnesses or major surgery within 4 weeks prior to the screening.
- •3. Patients with DSM-V diagnosis of substance-related disorders within 180 days before the date of screening.
- •4. Patients with concurrent condition of Parkinson disease (except for drug-induced extrapyramidal syndrome). Patients with history or presence of tardive dyskinesia. Patients with cognitive and motor impairment.
- •5. Patients with concomitant treatment with hepatic enzyme inhibitors (including fluoxetine or paroxetine) or medications known to interact with study medication within 2 weeks of the first injection of study medication.
- •6. Administration of thioridazine, or ziprasidone within 2 weeks of the first study-related procedure; receiving tablet paliperidone within 2 months of the first study-related procedure.
- •7. Presence of syncope or orthostatic hypotension (defined as systolic blood pressure decrease of at least 30 mmHg or a diastolic blood pressure decrease of at least 20 mmHg within one to three minutes of standing up).
- •8. Patients with uncontrolled hypertension
- •9. Patients with known cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration, hypovolemia or any medications).
- •10. Patients with inadequate mass in the deltoid or gluteal regions to receive the intramuscular drug injection.
- •11. Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
- •12. Patients with creatinine clearance (using Cockcroft Equation) less than 80 mL per min
- •13. Patients with severe hepatic impairment based on the Child-Pugh classification
- •14. Patients with diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within 12 months prior to screening, or diagnosis of substance abuse within 3 months prior to screening.
- •15. Donation of blood (greater than or equal to 1 unit or 350 mL) within 90 days prior to receiving the first dose of study medication or during the study.
- •16. Patient attempted suicide within 12 months before screening or current thoughts of suicide (suicidal ideation) or violent tendencies/ behavior.
- •17. Patients with positive result for any of the serology tests (Hepatitis B, C and HIV)
- •18. Patient with known hypersensitivity/ intolerance to study drug or any other component of the drug.
- •19. A history of granulocytopenia, agranulocytosis or myeloproliferative disorders (drug-induced or idiopathic).
- •20. Positive tests for drug or alcohol abuse at screening and/or baseline.
- •21. Receipt of an investigational medicinal product or participation in a drug research study within 90 days prior to receiving the first dose of study medication or during the study.
- •22. Psychosis judged to be the direct physiological effect of an abused medication or substance.
- •23. Hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period.
- •24. Patients with the following cardiac conditions are excluded:
- •a. Recent myocardial infarction (less than 12 months)
- •b.QTc prolongation (screening electrocardiogram with QTc greater than 450 msec for men, QTc greater than 470 msec for women as cal
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