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CTRI Number  CTRI/2024/02/062981 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study in Patients with Schizophrenia or Bipolar I Disorder already receiving a stable dose of Cariprazine capsules 6 mg 
Scientific Title of Study   A Multicentric, Open-label, Randomized, Two-Treatment, Two-sequence, Two-period, Cross-over, Multiple dose, Steady state Bioequivalence Study of Cariprazine Hard Capsules 6 mg of Rontis Hellas S.A, Greece (Test) with Reagila® 6 mg Hard Capsules of Gedeon Richter Plc. (Reference) in Schizophrenia or Bipolar I Disorder patients already receiving a stable dose of Cariprazine capsules 6 mg. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
P-66523  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr. Vishnupriya Bommareddy 
Designation  Project Manager 
Affiliation  QPS Bioserve India Pvt Ltd 
Address  QPS Bioserve India Pvt Ltd Plot No. 47, IDA, Balanagar, Hyderabad-500037, India

Hyderabad
TELANGANA
500037
India 
Phone  914068375555  
Fax    
Email  vishnupriya.bommareddy@qps.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Krishna Murthy Lakshman 
Designation  Project Director and Medical Monitor 
Affiliation  QPS Bioserve India Pvt Ltd 
Address  QPS Bioserve India Pvt Ltd Plot No. 47, IDA, Balanagar, Hyderabad-500037, India

Hyderabad
TELANGANA
500037
India 
Phone  00914023070874  
Fax    
Email  murthy.lakshman@qps.com  
 
Details of Contact Person
Public Query  
Name  Dr Krishna Murthy Lakshman 
Designation  Project Director and Medical Monitor 
Affiliation  QPS Bioserve India Pvt Ltd 
Address  QPS Bioserve India Pvt Ltd Plot No. 47, IDA, Balanagar, Hyderabad-500037, India

Hyderabad
TELANGANA
500037
India 
Phone  00914023070874  
Fax    
Email  murthy.lakshman@qps.com  
 
Source of Monetary or Material Support  
Rontis Hellas S.A. 38 Sorou Str., PC 15125, Athens, Marousi, Greece 
 
Primary Sponsor  
Name  Rontis Hellas S.A 
Address  38 Sorou Str PC 15125 Athens, Marousi Greece Tel 00302106109090 Fax 0030210 6108748  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Prasad Rao  Asha Hospital  Department of Phsychiatry,first floor,Road No 14,Banjara Hills,Hyderabad,Telangana-500 034
Hyderabad
TELANGANA 		 9985900005

prasad40@gmail.com 
Dr Dalaya Nitin Veersingh  Life Point Multispecialty Hospital Pvt Ltd  145-1, third floor Mumbai-Bangalore highway,Near Hotel Sayaji,Wakad,Pune,Maharashtra-411057,India
Pune
MAHARASHTRA 		 9552503210

drndalaya@gmail.com 
DrIVL Narasimha Rao  Manasa Hospital  Dr.IVL Narasimha Rao, Manasa Hospital. #13-1-43,Old club Road, Kothapet, Guntur, Andhra Pradesh-522001
Guntur
ANDHRA PRADESH 		 9849016620

manasahospitalguntur@gmail.com 
Dr Vora Vaishal Nareshchandra   Ratandeep Multispecialty Hospital  Ratandeep Multispecialty Hospital Nakshatra complex, Above HDFC Bank, Maninagar crossroads, Ahmedabad, Gujarat-380008
Ahmadabad
GUJARAT 		 9825440891

vnvora@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee Asha Hospital, Asha Hospital  Approved 
Institutional Ethics Committee Manasa Hospital  Approved 
Lifepoint Research- Ethics Committee  Approved 
Ratandeep Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F319||Bipolar disorder, unspecified, (2) ICD-10 Condition: F209||Schizophrenia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cariprazine Hard Capsules 6 mg(Test)  One Capsule Once Daily at the same time with or without food 
Comparator Agent  Reagila® 6 mg Hard Capsule (Reference)  One Capsule Once Daily at the same time with or without food 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Willing to participate and provide consent themself (or) by the Legally acceptable representative.
2. Meet the criteria for Schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) OR those for bipolar I disorder without psychotic features in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5)
3. Receiving a stable dose of Cariprazine 6 mg once daily for at least 04 weeks prior to screening
4. With no clinically significant abnormality in any of the laboratory parameters including ECG and Chest X ray
5. Female patients must have negative Urine pregnancy test result at screening. If of childbearing potential, they must be practicing an acceptable method of birth control during the study and till 60 days post last dose such as
• Intrauterine Device (IUD) abstinence or double barrier contraception
• Have been postmenopausal for at least 01 year if less than 1 year then use acceptable contraceptive measures listed above or
• Be surgically sterile (bilateral tubal ligation bilateral,tubectomy oophorectomy,or hysterectomy has been performed on the subject)
6. Male patients willing to follow an approved birth control method (a double barrier method) for the duration of the study as judged by the investigator and till 60 days post study such as condom with spermicide or condom with diaphragm,or abstinence. Subject should not donate sperm for 60 days.
 
 
ExclusionCriteria 
Details  1. History of Hypersensitivity to Cariprazine or any of the excipients (Brilliant blue FCF,Allura red AC,Titanium dioxide,Gelatin, Shellac,Black iron oxide,Propylene glycol and Potassium hydroxide)
2. With any psychiatric illness (other than Schizophrenia or bipolar disorder), neurological disorders including neurologic malignant syndrome,major depressive disorder,organic mental disorder,severe tardive dyskinesia,Parkinson’s disease,history or presence of epilepsy or risk of seizures,history of multiple syncopal episodes or stroke
3. Who had undergone exacerbation of Schizophrenia and ECT (Electro Convulsive therapy) within the two months before the date of Screening.
4. Hospitalization for an exacerbation of Schizophrenia within the 2 months before the date of screening.
5. With significant clinically relevant endocrinal,cerebrovascular, pulmonary,haematological, immunological and cardiovascular disease (Ex heart failure, history of myocardial infarction or ischemia, conduction abnormalities,cardiomyopathy, myocarditis),cerebrovascular disease, or conditions that predispose the patient to hypotension (Ex dehydration, hypovolemia,and treatment with antihypertensive medications). Could lead to safety risk.
6. Who answered yes to question 4 (active suicidal ideation with some intent to act,without a specific plan) or question 5 (active suicidal ideation with a specific plan and intent) for the time period of past 12 months from screening on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (CSSRS)
7. 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, including bradycardia, cardiac arrhythmias, hypokalemia or hypomagnesemia, concomitant use of other drugs that prolong the QTc interval; and presence of congenital prolongation of the QT interval (QTc ge 440 ms).
8. History of clinically significant eye disorders like increased intra ocular pressure or reduced visual acuity and cataracts.
9. Female subjects with a positive pregnancy test result or who are breastfeeding.
10. With a positive test result for HIV, HBsAg or HCV
11. Who are taking medicines used to treat Tuberculosis, Bacterial or Fungal infection, Cushing s syndrome, depression, epilepsy, seizures, heart disease, Sleepiness or Pulmonary Arterial Hypertension (PAH)
12. Use any of the following medications within the 04 weeks before enrolment:
• Strong inhibitors of CYP3A4
• Strong inducers of CYP3A4
• Drugs associated with QT prolongation.
• Any other drug that the investigator considers might adversely affect the wellbeing of the patient or influence the outcome of the study.
13. History of clinically significant cardiovascular, renal, hepatic, respiratory, endocrine (except noninsulin dependent diabetes mellitus), or gastrointestinal disease
14. History of difficulty with donating blood or difficulty in accessibility of veins.
15. Consumed grapefruit or mosumbi or sweet lime or their products within the 48 hours prior to enrolment.
16. Participated in a clinical trial or donated blood within the 90 days prior to enrolment.
17. Who had major surgery within the 2 months prior to study entry, or who have not recovered from prior major surgery.
18. History of venous thromboembolism or conditions that predispose the risk of embolism.
19. Medical or surgical condition that might interfere with the absorption, metabolism or excretion of Cariprazine.
20. With clinically significant hyperprolactinemia or Prolactinoma.
21. With known hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose galactose malabsorption.
22. Any condition or abnormal baseline findings that, in the Investigator judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the steady state bioequivalence (compare the rate and extent of absorption) of Cariprazine Hard Capsules 6 mg (Test) and Reagila® 6mg Hard Capsules of Gedeon Richter Plc. (Reference) in patients already receiving a stable dose of Cariprazine Capsules 6 mg.  Day 12, Day 13 and Day 14 and Day 26, Day 27 and Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the safety and tolerability of Cariprazine Hard Capsules 6 mg in patients with Schizophrenia or Bipolar I disorder, as assessed by reported adverse events, laboratory and clinical investigations and vital signs.  Day 12, Day 13 and Day 14 and Day 26, Day 27 and Day 28 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   To determine the steady state bioequivalence  of Cariprazine Hard Capsules 6 mg (Test) and Reagila® 6mg Hard Capsules of Gedeon Richter Plc. (Reference) in patients already receiving a stable dose of Cariprazine Capsules 6 mg. 
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