To compare Bioequivalence of two formulations of Risperidone Long Acting Injection 25 mg in patients with Schizophrenia or Bipolar I Disorder following multiple doses
Scientific Title of Study
Multicenter, Randomized, Two-Period, Two-Treatment, Two-Sequence, Multiple Dose, Steady-state, Crossover, Comparative Bioavailability Study of Mylan’s Risperidone Long Acting Injection 25 mg/vial with Janssen’s Risperdal Consta® 25 mg/vial in Subjects with Schizophrenia or Bipolar I disorder under Fasting Conditions
A-405, 4th Floow, Radhe Krishna Complex, 132 Ring Road, Near Jaymala Bus Stand, Isanpur, Ahmedabad, Gujarat-382443, India Ahmadabad GUJARAT
9825610315
v_sanghadia@yahoo.com
Dr C Ramasubramanian
Ahana Hospitals LLP
Clinical Research Department, Basement, No.7, Subburaman Street, Gandhi Nagar, Madhurai-625020, Tamil Nadu, India. Madurai TAMIL NADU
9843255444
drramasubramanian@gmail.com
Dr Rajendra Anand
Anand Multispeciality Hospital and Research Centre
Consulting Room Number -01,Psychiatry Department And Multispecialty Hospital & Research Centre, 4th floor, Sarthak Mall, Mahatma Mandir Road, Sargasan Cross Road, Gandhinagar-382421, Gujarat, India. Gandhinagar GUJARAT
9824017400
drrajendraanand@yahoo.com
Dr Magesh Rajagopal
Aram Hospital
No. 21, 4th cross, Ramalinganagar south Exention, Trichy - 620017, Tiruchirappalli, India Tiruchirappalli TAMIL NADU
9538800755
aramcrc@gmail.com
Dr PN Sureshkumar
Chethana Centre For Neuro Psychiatric Rehabilitation Centre
Chethana Centre For Neuro Psychiatric Rehabilitation Centre, Clinical Research Room, Providence College Rd, Malaparamba, Kozhikode, Kerala - 673009, India Kozhikode KERALA
9447218825
drpnsuresh@gmail.com
Dr Venu Gopal Jhanwar
Deva Institute of Healthcare and Research Pvt. Ltd.
B27/70 MN, Durgakund, Varanasi, Uttar Pradesh-221005, India Varanasi UTTAR PRADESH
9935571052
vgj.dihr@gmail.com
Dr Poorav Patel
J K Orthopaedic Hospital
3rd Floor, Clinical Research department, Behind Mehta Petrol Pump, Girdharnagar, Himmatnagar, Gujarat 383001, India Sabar Kantha GUJARAT
9428772609
drpooravpatel@gmail.com
Dr Keyur Parmar
Kiran Neuro-Psychiatry Care
309-3rd, Samved complex, Jail Road, Bhavnagar-364001, Gujarat, India Bhavnagar GUJARAT
9909903513
drkeyurparmar@gmail.com
Dr Prashant Agrawal
Pulse Hospital
2/4 Nehru Nagar(W), Near Gurudwara, Bhilai-490020, Chhattisgarh, India Durg CHHATTISGARH
7000402116
palSl184@qmail.com
Dr Vaishal Vora
Ratandeep Multispecialty Hospital
Nakshatra Complex, Above HDFC Bank, Maninagar Cross Roads, Maninagar, Ahmedabad , Gujarat ,380008, India. Ahmadabad GUJARAT
Risperidone Long Acting Injection administered intramuscularly every 14 days for 5 doses
Intervention
Risperidone Long Acting Injection 25 mg/vial
Risperidone Long Acting Injection administered intramuscularly. every 14 days for 5 doses
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise
1. Male or non-pregnant, non-lactating female between 18 and 65 years of age.
2. Subjects with BMI 18 to 35 kg/m2
3. Diagnosed with schizophrenia or Bipolar I disorder as per DSM-V criteria
4. Subjects with stable psychiatric symptoms
5. Currently stable on a regimen consisting of risperidone long-acting injection
6. Subjects with Clinical Global Impression - Severity of illness (CGI-S) score less than or equal to 4
7. Subjects with adequate hematological parameters
8. Subjects with adequate hepatic function
9. Subjects with Negative HIV, hepatitis B antigen, hepatitis C antibody, RPR or VDRL test
10. Subjects with negative urine drug screen
11. Subjects with negative X-ray for tuberculosis
ExclusionCriteria
Details
Subject candidates must not be enrolled in the study if they meet any of the following criteria:
1. Subjects with Known or suspected allergy or hypersensitivity to risperidone, paliperidone or similar drugs.
2. Diagnosis of alcohol or substance abuse during the 6-month period.
3. History or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease, organic mental disorder), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease.
4. History of uncontrolled diabetes, significant orthostatic hypotension uncontrolled hypertension, Parkinson’s disease, mood disorders or seizure disorder.
5. Subjects with dementia related psychosis.
6. Hospitalization due to exacerbation of psychiatric symptoms
7. Subjects with renal function abnormality.
8. Subjects with clinically significant hyperprolactinemia or with possible prolactin dependent tumor.
9. Subjects with blood dyscrasias.
10. Received Electroconvulsive Therapy (ECT)
11. Subjects with suicidal ideation score of 4 or 5 on Columbia Suicidal Severity Rating Scale.
12. Subjects who are on active treatment with drugs that are known to interact with risperidone.
13. History of neuroleptic malignant syndrome or tardive dyskinesia.
14. 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
15. Male or female of childbearing potential unwilling to use adequate method of contraceptive precautions throughout the study.
16. Subjects with clinically significant laboratory investigations as per the investigator’s judgment.
17. Any food allergy, intolerance, restriction or special diet
18. Participation in any interventional clinical study
19. History of difficulty with donating blood or difficulty in accessibility of veins.
20. Donation of blood
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the bioequivalence of Mylan’s Risperidone Long Acting Injection, 25 mg/vial with Janssen’s Risperdal Consta®, 25 mg/vial in subjects with schizophrenia or bipolar I disorder under fasting conditions
After 5th dose of period I and 3rd and 5th Dose of period II
Secondary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability of Mylan’s Risperidone Long Acting Injection 25 mg/vial in subjects with schizophrenia or bipolar I disorder.
Safety will be assessed throughout the study,
i.e., from signing of ICF to end of study visit
Target Sample Size
Total Sample Size="140" Sample Size from India="140" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="159"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A bioequivalence study with Risperidone Long Acting Injection 25 mg in patients with Schizophrenia or Bipolar I Disorder following objectives:
To evaluate the bioequivalence of Mylan’s Risperidone Long Acting Injection, 25 mg/vial with Janssen’s Risperdal Consta®, 25 mg/vial in subjects with schizophrenia or bipolar I disorder under fasting conditions.
To evaluate the safety and tolerability of Mylan’s Risperidone Long Acting Injection 25 mg/vial in subjects with schizophrenia or bipolar I disorder.