CTRI/2021/06/034105尚未招募未知
A Randomized, Open Label, Two Stage, Multicentre, Parallel Group, Multiple Dose, Steady State Study to Compare Bioavailability and Characterize Pharmacokinetic Profile of Test Formulation[Paliperidone Palmitate Extended Release Injectable Suspension By Accord Healthcare,Administered Every Three Months] Relative to Reference Formulation [Invega Trinza®(Paliperidone Palmitate Extended Release Injectable Suspension) By Janssen Pharmaceuticals]and to Establish Bioequivalence in Patients with Schizophrenia Already Receiving A Stable Regimen of Paliperidone Palmitate Extended Release Injectable Suspension.
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入排标准
入选标准
- •1.Participants and their legally acceptable representative must sign an ICF indicating that he or she understands the purpose of, and procedures required for the study as described in in this protocol and is willing to participate in the study.2.Male or female participant must be between 18 to 75 years of age (both inclusive), at the time of signing the informed consent.3.Participants having body mass index (BMI) between 18 and 30 kgm² (BMI weightandheight2), inclusive, and at least 50 kg weight for male patients and 48 kg for female patients.4.Participants who met diagnostic criteria for schizophrenia according to DSM-5 criteria as per institutional practice. If participants have been initially diagnosed with DSM IV criteria than diagnosis should be reconfirmed as per DSM-5 criteria according to standard institutional practice.5.Participants must be clinically stable, defined as no hospitalizations for acute exacerbations, no changes in any antipsychotic medication within 3 months and CGI (severity) scale more than 4 at screening and randomization.6.Participants who are medically stable on the basis of physical examination, medical history, and vital signs and 12-lead ECG performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant source documents and initialed by the investigator.7.Participants who are medically stable on the basis of clinical laboratory tests performed at screening and baseline. If the results of the serum chemistry panel are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participants source documents and initialed by the investigator.8.Participants, who are at randomization visit,stabilized on 156 mg 1.5 mL dose of paliperidone palmitate extended release (156 mg paliperidone palmitate equivalent to 100 mg paliperidone) injectable suspension once every month (at least 4 doses (apart from the 234 mg loading dose) prior to randomization) would be eligible for randomization in the study at the Investigators discretion OR Patients, who are at randomization visit,already stabilized (at least one dose) on 546 mg 1.75 mL(546 mg paliperidone palmitate equivalent to 350 mg paliperidone) of Paliperidone Long-acting injection once every 3 months would be eligible for randomization in the study at the Investigators discretion.9.A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies-•Is not a woman of childbearing potential (WOCBP)OR•Is a WOCBP and using an acceptable contraceptive method as described in Appendix 10.4 for at least 4 weeks prior to start of stabilization period or prior to study drug administration (as applicable),during the intervention period or stabilization period (as applicable) and for at least 6 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the intervention period or stabilization period (as applicable) and for at least 6 months after the last dose of study intervention. Cessation of birth control after this point should be discussed with a responsible physician. The investigator should e
排除标准
- •1.History of clinically significant liver or renal insufficiency, cardiac, vascular,pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances as per investigators discretion.
- •2.Known allergies, hypersensitivity, or intolerance to risperidone, Paliperidone or to any excipients in study medications as per prescreening information of Invega Trinza.
- •3.Contraindications to the use of risperidone or Paliperidone long acting injection as per prescreening information of Invega Trinza.
- •4.History of no response to risperidone or paliperidone when psychotic or acutely psychotic. Lack of response is defined as participants who have had a documented medical history of no clinical response, despite adequate doses and durations of treatment, or the inability to tolerate effective doses.
- •5.Participants with history or presence of neuroleptic malignant syndrome (NMS),tardive dyskinesia, dementia-related psychosis, mood disorders or seizure disorder and Parkinsons disease at Screening and randomization visit.
- •6.Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •7.Had major surgery, (eg, requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study.
- •8.Participants with inadequate mass in the deltoid or gluteal regions to receive the intramuscular drug injection as clinically assessed by the investigator.
- •9.History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- •10.History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening.
- •11.History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 6 months before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, and amphetamines) (except for benzodiazepines which are permissible when supported by a prescription) at screening and at randomization visit.
- •12.Patients with known cerebrovascular disease (e.g. stroke).
- •13.Patients with poorly controlled diabetes mellitus (defined as failure to achieve appropriate HbA1c goal based on clinical guidelines despite diabetes self-management education, appropriate glucose monitoring, and effective doses of multiple glucose-lowering agents including insulin or other patient-specific condition) at the time of screening.
- •14.Patients with uncontrolled hypertension (systolic BP more than 140 mmHg/diastolic BP less than 90 mmHg) at the time of screening and at randomization visit.
- •15.Presence of syncope or orthostatic hypotension (defined as systolic blood pressure decrease of at least 20 mmHg or a diastolic blood pressure decrease of at least 10 mmHg within one to three minutes of standing up) at the time of screening and randomization.
- •16.History or presence of significant hyperprolactinemia due to causes other than antipsychotic drugs use at screening.
- •17.History or p
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