Study of Paliperidone Palmitate injection 156mg/mL with INVEGA SUSTENNA® Injectable Suspension 156mg/mL in subjects with schizophrenia.
- Conditions
- Health Condition 1: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2020/05/025244
- Lead Sponsor
- Qilu Pharmaceutical Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Willing and able to provide voluntary informed consent and to follow the protocol requirements.
2.Subject aged 18-65 years (both inclusive) having body mass index (BMI) between 17.00 and 30.00 (both inclusive) calculated as weight in kg/height in m2.
3.Subjects with diagnosis of schizophrenia as per DSM-IV-TR criteria or later.
4.Subjects receiving Paliperidone long-acting injection at a dose of 156mg/mL via the intramuscular route and have completed at least 2 doses prior to randomization.
5.Acceptable hematology status:
a.Hemoglobin more than or equal to 9 g/dL
b.Absolute neutrophil count (ANC) more than or equal to 1500 cells / microlitre
c.Platelet count more than or equal to 100,000 cells/ microliter
6.Acceptable liver function:
a.Alanine aminotransferase (ALT) less than or equal to 2X upper limit of normal (ULN)
b.Aspartate aminotransferase (AST) less than or equal to 2X ULN
c.Bilirubin less than 1.2 mg/dL
d.Alkaline phosphatase less than or equal to 2X ULN
7.Subjects with creatinine clearance more than or equal 80 mL/minute.
8.Female subjects with negative serum pregnancy test at screening.
9.Females of child bearing potential must be willing to use adequate contraception (as defined below) throughout the study and continuing for at least 3 months after the last dose of the investigational product. For this study, acceptable and effective methods of contraception for females include:
a.Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period,
b.Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or
c.Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner).
10.For male subjects, one of the following must apply in order to avoid impregnating a female partner, from the first study dose and agree to follow throughout the study and for at least 3 months following the last dose of the study.
a.Absolute sexual abstinence (no sexual intercourse or genital contact with a female partner).
b.Use of barrier method with spermicide
11.No history of addiction to any recreational drug or drug dependence or alcohol addiction.
1.Hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients.
2.Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening.
3.History or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, dementia-related psychosis, Parkinsonâ??s disease or epilepsy/seizures.
4.Subjects on different antipsychotic treatment.
5.Subjects with congenital long QT syndrome.
6.Subjects with history of arrhythmia.
7.Subjects with positive urine screen for Drug of Abuse. (Except for benzodiazepine which is a permissible medication supported by prescription)
8.Uncontrolled clinically significant major cardiac, liver or kidney disease, diabetes mellitus etc.
9.Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
10.Any clinically significant abnormal laboratory parameter evaluated during screening.
11.Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
12.Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study that would limit adherence to study requirements.
13.Participation in any clinical study within 90 days before the first Investigational Product administration.
14.Donation and/or loss of more than or equal to 350 mL (1 unit) of blood within 90 days prior to first dose of Investigational Product for the current study.
15.Lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the steady-state bioequivalence of Paliperidone Palmitate injection 156mg/mL of Qilu Pharmaceuticals Co., Ltd. with INVEGA SUSTENNA® (Paliperidone Palmitate) ER Injectable Suspension 156mg/mL of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in subjects with schizophrenia.Timepoint: The IP will be administered on Day 1, 29, 57, 85, 113 and 141 of the study at study site.Prior to dosing on day 85 (Pre-dose blood sample), 113 (Pre-dose blood sample), 141 (Pre-dose blood sample (00.00) hours) & Post dose 8 hours & on day 142 (24 hours), 143 (48 hours), 144 (72 hours), 145 (96 hours), 146 (120 hours), 147 (144 hours), 148 (168 hours), 151 (240 hours), 154 (312 hours), 157 (384 hours), 160 (456 hours), 163 (528 hours), 166 (600 hours) & 169 (672 hours)
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of subjects.Timepoint: The IP will be administered on Day 1, 29, 57, 85, 113 and 141 of the study at study site.Prior to dosing on day 85 (Pre-dose blood sample), 113 (Pre-dose blood sample), 141 (Pre-dose blood sample (00.00) hours) & Post dose 8 hours & on day 142 (24 hours), 143 (48 hours), 144 (72 hours), 145 (96 hours), 146 (120 hours), 147 (144 hours), 148 (168 hours), 151 (240 hours), 154 (312 hours), 157 (384 hours), 160 (456 hours), 163 (528 hours), 166 (600 hours) & 169 (672 hours)