Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Risperidone Long Acting Injection 25 mg/Vial: Dose Formulation-Vial,Unit Dose Strength(s)Each vial contains:Risperidone 25 mg,Dosage Level(s) 25 mg IM (gluteal injection as per randomiz
Sponsors
Intas Pharmaceuticals Ltd., India
INTAS PHARMACEUTICALS LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for the study in this protocol and is willing to participate in the study 2.Male or female participant must be 18 to 65 (both inclusive) years of age inclusive, at the time of signing the informed consent. 3.Participants who are medically stable on the basis of physical examination, medical history, and vital signs, and 12-lead ECG performed at screening and at randomization. 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. 4.Participants who are medically stable on the basis of clinical laboratory tests performed at screening and at randomization. If the results of the serum chemistry panel, hematology, or urinalysis 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 participant source documents and initialed by the investigator. 5.Participants with confirmed documented diagnosis of Schizophrenia as per DSM- V criteria at screening. If participants have been initially diagnosed with DSM IV criteria than diagnosis should be reconfirmed as per DSM V criteria according to standard institutional practice. 6.Participants with either of following scenario supported by documented medical history at screening: every two weeks (at least 2 doses) prior to randomization.who are stable and tolerating on oral Risperidone and have been prescribed treatment with Risperidone long acting injection 25 mg once every two weeks as per the clinical judgment of the treating physician and will be initiating the treatment as per the approved SmPC. who are already receiving and tolerating on Risperidone long-acting injection 25 mg once every two weeks (for less than 2 doses) prior to randomization. 7.Participants having body weight at least 50 kg for male and 48 kg for female and body mass index (BMI) within the range [18 – 30] kg per m2 (both inclusive) at screening and at randomization. 8.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 a contraceptive method that is highly effective (with a failure rate of more than 1% per year), with low user dependency when used consistently and correctly, as described in Appendix 0 during the intervention period and for at least 3 months, after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of at least 3 months, after the last dose of study intervention The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. WOCBP must have a negative pregnancy test within 24 hours at screening and at randomization visit (before the first dose of study intervention) as applicable (serum or urine). If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In suc
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1. History or current evidence of clinically significant moderate hepatic impairment (Child-Pugh class B or more); History of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (other than schizophrenia), or metabolic disturbances. 2.Known allergies, hypersensitivity, or intolerance to Risperidone, Paliperidone or to any excipients in study medications. 3.Contraindications to the use of Risperdal CONSTA® (Risperidone)[1] long acting injection. 4.Participants with history or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, dementia-related psychosis, mood disorders or seizure disorder and Parkinsons disease as assessed by the investigator. 5.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. 6.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. NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. 7 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. 8 History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening. 9 History of drug or alcohol abuse within 6 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) (except for benzodiazepines which are permissible when supported by a prescription) at screening. 10.Patients with known cerebrovascular disease (e.g. stroke). 11 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. 12.Patients with uncontrolled hypertension (systolic BP = 150 mmHg/diastolic BP = 100 mmHg) at the time of screening and randomization. 13.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. 14.History or presence of clinically significant hyperprolactinemia as determined by investigator due to causes other than antipsychotic drugs use at screening. 15.QTc greater than 450 msec for male participants or QTc greater than 470 msec for female participants or QTc greater than 480 msec in participants with bundle branch block.The QTc is the QT interval corrected for heart rate according to Fridericia’s formula (QTcF). It is either machine-read or manually over-read. 16.Patients who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetic profile and to assess the bioequivalence of Risperidone long acting injection 25 mg relative to Risperdal CONSTA® (Risperidone) long acting injection 25 mg in patients needing maintenance treatment for SchizophreniaTimepoint: Pre-dose Samples: Dose 4 (Day 43), Dose 5 (Day 57), Dose 6 (Day 71), Dose 7 (336.000 h of Dose 6) (Day 85), Dose 11 (Day 141), Dose 12 (Day 155), Dose 13 (Day169) and Dose 14 (336.000 h of Dose 13) and (Day 183). Post-dose Samples: 0.500, 1.000, 2.000, 4.000, 8.000, 12.000, 24.000 (Day 2), 48.000 (Day 3), 72.000 (Day 4), 96.000 (Day 5), 144.000 (Day 7), 192.000 (Day 9), 240.000 (Day 11), 288.000 (Day 13) and 336.00. | — |
Secondary
| Measure | Time frame |
|---|---|
| To further characterize the pharmacokinetic profile & to assess the bioequivalence of Risperidone long acting injection 25 mg relative to Risperdal CONSTAA (Risperidone) long acting injection 25 mg in patients needing maintenance treatment for SchizophreniaTimepoint: Pre-dose Samples: Dose 4 (Day 43), Dose 5 (Day 57), Dose 6 (Day 71), Dose 7 (336.000 h of Dose 6) (Day 85), Dose 11 (Day 141), Dose 12 (Day 155), Dose 13 (Day169) & Dose 14 (336.000 h of Dose 13) & (Day 183). Post-dose Samples: 0.500, 1.000, 2.000, 4.000, 8.000, 12.000, 24.000 (Day 2), 48.000 (Day 3), 72.000 (Day 4), 96.000 (Day 5), 144.000 (Day 7), 192.000 (Day 9), 240.000 (Day 11), 288.000 (Day 13) & 336.00. | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Limited
Outcome results
None listed