Two-treatment Bioequivalence Study of Paliperidone Palmitate in adult schizophrenic patients
- Conditions
- Health Condition 1: F259- Schizoaffective disorder, unspecifiedHealth Condition 2: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2023/06/054479
- Lead Sponsor
- American Regent, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Male & Female having a documented clinical diagnosis of schizophrenia or schizoaffective disorder according to the PI evaluation and Diagnostic and Statistical Manual of Mental Disorders, 5th edition (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 =18-35 kg / m2 and at least 50 kg weight for male participants and 48 kg for female participants.
5.Participants who at screening are at a stable regimen of oral Paliperidone or Risperidone therapy or who are already receiving Paliperidone palmitate 156 mg/mL (100 mg Paliperidone) extended-release intramuscular injectable suspension and who at randomization are receiving a stable regimen of 156 mg/mL (100 mg Paliperidone) of monthly paliperidone palmitate extended-release suspension 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 < 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 during screening.
9.In case of Male participants: Either partner or participant must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during the study and till the end of study. Cessation of birth control after this point should be discussed with a responsible physician.
10.Women of non-childbearing potential with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy at least 6 months prior to IMP administration) or postmenopausal for at least 12 consecutive months.
Participants who meet any of the following criteria will not be enrolled in the study:
1.Participant with known hypersensitivity and/or intolerance to study drug or any other component of the drug or intolerance to oral paliperidone/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 (torsade de pointes and/or conditions that can lead to sudden death or participants receiving drugs that prolong QTc interval, including: bradycardia, cardiac arrhythmias, hypokalemia or hypomagnesemia, concomitant use of other drugs that known to prolong the QTc interval, and prolonged QT interval (QTc > 450 msec in male participants or QTc > 470 msec in female participants, QTc interval to be calculated with Bazett’s Formula) at screening and randomization.
6.Participants with current or relevant history of psychiatric illness except schizophrenia.
7.Participants with clinically significant illnesses or Participant had major surgery within 4 weeks prior to first dosing, 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 within 2 weeks of the first injection of study medication.
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 = 150 mmHg/diastolic BP = 100 mmHg).
13.Participants with known cerebrovascular disease, or conditions that predispose the participant to hypotension (e.g., dehydration, hypovolemia and treatment with antihypertensive medications).
14.Participants with inadequate mass in the deltoid/gluteal regions to receive the intramuscular drug injection.
15.Participants with severe hepatic impairment based on the Child-Pugh classification (Child-Pugh category C).
16.Participants with a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period prior to screening.
17.Donation of blood (= 1 unit or 350 mL) within 90 days prior to receiving the first dose of study medication or
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish bioequivalence between the American Regent Inc. Test Product of Paliperidone Palmitate extended-release intramuscular injectable suspension (156 mg/mL) & the Reference Product INVEGA SUSTENNA® kit (paliperidone palmitate) extended-release intramuscular injectable suspension (156 mg/mL) in adult patients with schizophrenia & schizoaffective disorders.Timepoint: A total of 58 blood samples each of 03 mL will be collected from each participantfor PK assessment <br/ ><br>during the study. All the post-dose PK blood samples till 48.00 hr. should be collected within ± <br/ ><br>2 minutes from the scheduled sampling time.
- Secondary Outcome Measures
Name Time Method To document the safety & tolerability of paliperidone palmitate intramuscular injections (test and reference products) in adult patients with schizophrenia and schizoaffective disordersTimepoint: At Screening, at each dosing (at the time of check in on days 0, 140, 112 & 252) and end of study (EOS) visit, there will be physical examination, vitals signs will be performed by investigator.