Two-treatment Bioequivalence Study of Paliperidone Palmitate in adult schizophrenic patients
- Conditions
- Health Condition 1: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2024/02/062550
- Lead Sponsor
- Eugia Pharma Specialities Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or non-pregnant, non-lactating females aged 18-65 years (both inclusive) having a documented clinical diagnosis of schizophrenia or schizoaffective disorder according to the PI evaluation and
Diagnostic and Statistical (DSM-V).
2. Participant is willing to participate for the entire study and adhere to the study protocol and committed
for required clinic visits and dosing.
3. Written informed consent for participation in the study by the participant and participant’s legally acceptable representative (LAR) and willing to adhere to protocol requirements.
4. Participants having BMI between less the or equal to 18.00 - 30.00 kg per m2 (Both inclusive) and at least 50 kg weight for male participants and 48 kg for female participants.
5. Participants who at screening are on stable regimen of oral Paliperidone or Risperidone therapy or who are already receiving Paliperidone palmitate 156 mg per mL (100 mg Paliperidone) extended-release intramuscular injectable suspension and who at randomization are receiving a stable regimen of 156 mg per mL (100 mg Paliperidone) of monthly paliperidone palmitate extended-release suspension (at least 3 doses) via the intramuscular route.
6. Participants who are clinically stable and not hospitalized for exacerbation of psychiatric symptoms for at least 3 months before randomization.
7. Participants having treatment response score of less than 4 (unchanged or worse and side-effects outweigh the therapeutic effects) as evaluated using Clinical Global Impression scale by investigator at both screening and Baseline visits.
8. Participants not having any significant diseases or clinically significant abnormal findings except schizophrenia or schizoaffective disorder during screening.
9. Adequate organ and bone marrow function at screening and randomization.
1. Participants with known hypersensitivity and or intolerance to study drug or any other component of the
drug or intolerance to oral paliperidone or risperidone prior to screening.
2. Pregnant or participants with childbearing potential not practicing contraceptive or other barriers of contraception.
3. Participants with a history of Neuroleptic Malignant Syndrome (NMS) while on treatment with antipsychotics.
4. History or presence of clinically significant cardiovascular disease, especially known history of QT prolongation, congenital long QT syndrome, recent acute myocardial infarction, cardiac arrythmias or uncompensated heart failure.
5. Participants with the QT prolongation risk. QTC more than 450 ms in male, QTC more than 470 ms in female .
6. Participants with current or relevant history of psychiatric illness except schizophrenia.
7. Participants with clinically significant illnesses or participant that have had major surgery within 4 weeks prior to first dosing of IMP and stabilization (if applicable), or who have not recovered from prior major surgery.
8. Participants with concurrent condition of Parkinson disease (except for drug-induced extrapyramidal
syndrome). Participants with history or presence of tardive dyskinesia. Participants with cognitive and
motor impairment.
9. Participants with concomitant treatment with hepatic enzyme inhibitors (including fluoxetine or
paroxetine) or medications known to interact with study medication or stabilization dose (if applicable)
within 2 weeks of the first dose.
10. Treatment with any of the following therapies:
Injection of risperidone long-acting injection within 6 weeks before randomization.
Electroconvulsive therapy within 3 months prior to screening.
Clozapine within 3 months before screening
11. 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).
12. Participants with uncontrolled hypertension (systolic BP more than 150 mmHg diastolic BP more than 100 mmHg).
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish Bioequivalence between Test and Reference productTimepoint: A total of 50 blood samples each of 03 mL will be collected from each participant for PK assessment during the study as below: <br/ ><br> <br/ ><br>Pre-dose: Dose 3, Dose 4 and Dose 5 of each period. <br/ ><br> <br/ ><br>Post-Dose (after Dose 5): 6.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00, 144.00, 168.00, 192.00, 216.00, 240.00, 264.00, 288.00, 312.00, 336.00, 360.00, 408.00, 456.00, 504.00, 576.00 and 672.00 hours after administration of 5th dose in each period.
- Secondary Outcome Measures
Name Time Method To document the safety & tolerability of the patients exposed <br/ ><br>to paliperidone palmitate intramuscular injections (test & reference products) in the study.Timepoint: Screening, At each dosing, check in Day 0, Day 140, Day 112, & Day 252 & at each ambulatory visit & during EOS visit. However, additionally on dosing day 113 & 253 vitals (Body temperature, Blood pressure, Heart rate & Respiratory rate) will be measured 1 hour prior <br/ ><br>to dosing & at 6.00, 12.00, 24.00, 48.00 hours post dose.