Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: Risperidone Long acting Injection 25 mg/vial: Amneal EU, Limited
Control Intervention1: Rispolept® Consta® 25 mg Risperidone powder and solvent for injectable suspension prolonged rel
Sponsors
Amneal EU Limited
Dr Sharwan Kumar Singhal DGM
Mr Alpesh Viradiya Sr Manager
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria. 2.Subjects with body mass index between 18.0 to 30.0 kg/ m2 (both inclusive) and aged between 18 to 65 years (both inclusive). Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent) d. Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject) e. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation f. Total abstinence, partial abstinence is not acceptable. 3.Subjects who are already receiving Risperidone prolonged-release suspension for intramuscular injection 25 mg/vial every two weeks and who have received at least four (4) doses 4.Subjects with no significant abnormality in ECG. 5.Subjects willing to comply with the visit schedule and able to adhere to the lifestyle restrictions specified in this protocol. 6.Subjects must be clinically stable, defined as no hospitalizations for acute exacerbations, no changes in any antipsychotic medication within 3 months and CGI (severity) scale score of 2-4 (both inclusive) at screening and randomization. 7.Subjects with adequate hematological reserve at screening. a.Hemoglobin >=9 gm/dL b.WBC (white blood cells) >=4000/c.mm c.ANC >= 1500/mm3 d.Platelets >=100,000/mm3 9.Subjects with adequate renal function at screening as defined by Creatinine clearance >= 60 mL/minute at screening. 8. Subjects with adequate and stable hepatic function at screening as defined by bilirubin less than 1.2 mg/dL and AST/ALT less than or equal to 2 X ULN 10.Females of childbearing potential with negative serum pregnancy test at screening. 11. Women of childbearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any two acceptable methods of contraception. a.Oral or other (e.g., injection, patch or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication Intrauterine device or intrauterine system 12. Male participants are eligible to participate if they agree to the following criteria during the intervention period and for at least three months after the last dose of study intervention: a. Must agree not to donate sperm for the purpose of reproduction. b. Must agree to use contraception / double barrier methods (e.g., condom and occlusive cap or condom and spermicidal agent) 13. Subject and the legally authorized representative (LAR) must demonstrate adequate decision â?? making ability in order to make an informed choice about participating in this study by providing written informed consent. Illiterate subjects can be considered when performed according to GCP, as well as regulations/guidance of DCGI. 14. Negative Hepatitis B &C, HIV 15. Subjects with negative urine screen for drugs of abuse (except for benzodiazepines which are permissible when supported by a prescription) and urine alcohol test at screening and randomization visit.
Exclusion criteria
Exclusion criteria: 1.Subjects with known allergies, hypersensitivity, or intolerance to Risperidone, Paliperidone, heparin or to any excipients of study drug and contraindications to the use of Rispolept Consta® long-acting injection. 2.Subjects with uncontrolled hypertension (i.e., BP greater than 150/100 mm of Hg). 3.Subjects with significant orthostatic hypotension at screening or before check-in on day 1; average of two orthostatic hypotension measurements will be considered when there is drop in systolic blood pressure of 20 mm Hg or more or diastolic blood pressure of 10 mm Hg or more on standing from supine measurements. 4.Subjects with inadequate mass in the gluteal regions to receive intramuscular drug injection. 5.Institutionalized subjects 6.Subjects who are having concurrent primary psychiatric (other than schizophrenia) or neurological diagnosis, including Neuroleptic malignant syndrome (NMS), dementia related psychosis, organic mental disorder, tardive dyskinesia, mood disorders, Parkinsonâ??s disease, priapism, history or presence of epilepsy or other conditions that potentially lower the seizure threshold, history of cerebrovascular disease. 7. History or presence of uncontrolled diabetes mellitus. 8.History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including: bradycardia, cardiac arrhythmias, hypokalemia or hypomagnesemia, concomitant use of other drugs that known to prolong the QTc interval (e.g. Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval); and presence of prolonged QT interval at screening (QTc greater than 450 msec in male subject or QT cgreater than 470 msec in female subjects, QTc interval calculated with Bazettâ??s Formula: QTCorrected equal to (QT Interval / sqr (RR Interval) ? ? ? ? ?? equal to ? ? /â?? ? R Where QT is the QT interval and RR is the interval from the onset of the QRS complex to the onset of the next QRS complex. Note If the subject was on any of these drugs, sufficient wash out period (of at least 5 half-lives) must have elapsed since the last dose of such drug before the first dose of investigational medicinal product for the current study. 9. Subjects who are having Hyperprolactinemia greater than or equal to 200ng/mL or greater than 200ng/mL with associated clinical symptoms at screening. 10. Pregnant or lactating women. 11. Subjects with history/presence of venous thromboembolism. 12. Subjects who are on active treatment with drugs that are known to interact with risperidone (such as Strong CYP2D6 inhibitors, CYP3A4. Note: If the subject was on any of these drugs, sufficient wash out period (of at least 5 half- lives) must have elapsed since the last dose of such drug before the first dose of investigational medicinal product for the current study (Refer appendix 5). 13. Subjects with medical or surgical condition that might interfere with the absorption, metabolism, or excretion of risperidone. 14. Subjects who undergone major surgery within 4 weeks prior to study entry, or who have not recovered from pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare and evaluate steady state pharmacokinetic profile of Risperidone Long acting Injection 25 mg/vial (test product) and Rispolept® Consta® 25 mg Risperidone powder and solvent for injectable suspension prolonged release (reference product)Timepoint: The Serial blood samples will be collected following the 5th dose in period-I and the 3rd and 5th doses in period-II at the following times 1.00, 1.50, 2.00, 3.00, 4.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00, 144.00, 192.00, 240.00, 288.00, 336.00. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability assessment of test product compared to reference product by monitoring adverse events.Timepoint: The post dose PK samples will be collected on day 57 at 1.00, 1.50, 2.00, 3.00, 4.00, 8.00, 12.00 hours, 24.00hours (day 58) post dose and ambulatory sample collection on day 59, day 60, day 61, day 62, day 63, day 65, day 67, day 69, and day 71 | — |
Countries
India
Contacts
Public ContactDr Sudershan Vishwanath
Vimta Labs Ltd.
Outcome results
None listed