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CTRI Number  CTRI/2018/09/015704 [Registered on: 13/09/2018] Trial Registered Prospectively
Last Modified On: 11/09/2019
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of Risperidone in patients with schizophrenia or bipolar I disorder. 
Scientific Title of Study   A multicenter, open label, balanced, randomized, two-treatment, two-period, two-sequence, two-way crossover, multiple dose, steady-state bioequivalence study of Risperidone Long-acting intramuscular injection of Qilu Pharmaceuticals Co. Ltd. with RISPERDAL CONSTA® (Risperidone) LONG-ACTING INJECTION of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in patients with schizophrenia or bipolar I disorder. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CBCC/2018/002 Version 1.0, dated 07/Jun/2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP India 
Address  Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP India 
Address  Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP India 
Address  Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Qilu Pharmaceutical Co.,Ltd 
 
Primary Sponsor  
Name  Qilu Pharmaceutical Co Ltd 
Address  317 Xinluo Road, High-Tech Zone, Jinan, Shandong, China 250100 E-mail: shuning.lin@qilu-pharma.com 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Contractor  Bodyline Hospital  Opp Annapurna Hall Near Dev Status New Vikas Gruh Road Paldi Ahmedabad 380007
Ahmadabad
GUJARAT 
9824012867

drashishcontractor.cr@gmail.com 
Dr Rajendra Anand  Kanoria Hospital and Research Centre  Airport Gandhinagar Highway Village Bhat Gandhinagar 382428
Gandhinagar
GUJARAT 
9824017400

drrajendraanand@yahoo.com 
Dr Bakul Buch  Shri Hatkesh Healthcare Foundation  Saraswati Mandir Complex Near Bhutnath Temple College Road Junagadh 362001
Junagadh
GUJARAT 
9825220330

bakulbuch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Bodyline Hospital Ethics Committee  Approved 
Hatkesh Healthcare Foundation Ethics Committee  Approved 
Kanoria Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F209||Schizophrenia, unspecified, (2) ICD-10 Condition: F319||Bipolar disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  RISPERDAL CONSTA® (Risperidone) LONG-ACTING INJECTION  RISPERDAL CONSTA® (Risperidone) LONG-ACTING INJECTION 25 mg/vial of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560  
Intervention  Risperidone Long-acting intramuscular injection   Risperidone Long-acting intramuscular injection 25 mg/vial of Qilu Pharmaceuticals Co. Ltd.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Willing and able to provide voluntary informed consent and to follow the protocol requirements.
2.Patient 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.Patients with diagnosis of Schizophrenia or Bipolar I Disorder as per DSM-IV-TR criteria or later.
4.Patients receiving Risperidone long-acting injection at a dose of 25mg/vial via the intramuscular route and have completed at least 2 doses prior to randomization.
5.Acceptable hematology status:
a.Hemoglobin greater than or equal to 9 g/dL
b.Absolute neutrophil count (ANC) greater than or equal to 1500 cells/µL
c.Platelet count greater than or equal to 100,000 cells/µL
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.Patients with Creatinine clearance greater than or equal to 60 mL/minute
8.Female patients with negative urine pregnancy test on admission day and 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 patients, 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.
 
 
ExclusionCriteria 
Details  1.Hypersensitivity to Risperidone or Paliperidone 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, Parkinson’s disease or epilepsy/seizures.
4.Patients with positive urine screen for Drug of Abuse.
5.Patients who are on active treatment with drugs that are known to interact with risperidone (such as Strong CYP2D6 inhibitors, CYP3A4 enzyme inducers).
6.Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
7.Patients on different antipsychotic treatment.
8.Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
9.Surgical or other non-healing wounds.
10.Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
11.Uncontrolled diabetes mellitus.
12.An unusual or abnormal diet, for whatever reason planned e.g. religious fasting during the course of the study.
13.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.
14.Participation in any clinical study within 90 days before the first dose of Investigational Product.
15.Donation and/or loss of 350 mL (1 unit) of blood within 90 days prior to first dose of Investigational Product for the current study.
16.Patient is currently Pregnant or breastfeeding.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To establish bioequivalence between Risperidone Long-acting intramuscular injection 25 mg/vial of Qilu Pharmaceuticals Co. Ltd. and RISPERDAL CONSTA® (Risperidone) LONG-ACTING INJECTION 25 mg/vial of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560  The pre-dose blood sample (00.00) will be drawn within 10 minutes prior to the scheduled dosing time on day 1, 43, 57 and 71 in Period 01 and on day 113, 141 and 155 in Period 02.
Post-dose blood samples after investigational product administration on day 1 and 15: 24.00, 48.00, 72.00, 96.00, 144.00, 192.00, 240.00, 288.00 and 336.00 hours and on day 71, 113 and 155: 12.00, 24.00, 48.00, 72.00, 96.00, 144.00, 192.00, 240.00, 288.00 and 336.00 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to assess safety of patients  NA 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2018 
Date of Study Completion (India) 18/05/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This study is A multicenter, open label, balanced, randomized, two-treatment, two-period, two-sequence, two-way crossover, multiple dose, steady-state bioequivalence study of Risperidone Long-acting intramuscular injection of Qilu Pharmaceuticals Co. Ltd. with RISPERDAL CONSTA® (Risperidone) LONG-ACTING INJECTION of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in patients with schizophrenia or bipolar I disorder.

Primary Objective: To assess the steady-state bioequivalence of Risperidone Long-acting intramuscular injection of Qilu Pharmaceuticals Co. Ltd. with RISPERDAL CONSTA® (Risperidone) LONG-ACTING INJECTION of Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 in patients with schizophrenia or bipolar I disorder who are already receiving a stable regimen of Risperidone long-acting injection via the intramuscular route.

Secondary Objective: To monitor the adverse events and to ensure the safety of Patients.

 
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