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CTRI Number  CTRI/2019/04/018793 [Registered on: 25/04/2019] Trial Registered Prospectively
Last Modified On: 15/11/2019
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Study of Cariprazine Capsules 6 mg in Schizophrenia or Bipolar disorder I patients who are receiving Cariprazine capsules 6 mg as stable dose 
Scientific Title of Study   A Multicentric, Open-label, Randomized, Two-Treatment, Two-sequence, Two-period, Cross-over, Multiple dose, Steady state Clinical Bioequivalence Study of Cariprazine Capsules 6 mg of Aurobindo Pharma Limited, India (Test) with VRAYLAR (Cariprazine) Capsules 6 mg of Allergan USA, Inc. Irvine, CA 92612, USA (Reference) in patients already receiving a stable dose of Cariprazine capsules 6 mg. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CR193-18 Version 1.0 Dated 04.07.2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSubhra Lahiri 
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd 
Address  Axis Clinicals Limited,1-121/1 Miyapur, Hyderabad

Hyderabad
TELANGANA
500049
India 
Phone  8886221089  
Fax  04040408060  
Email  Subhra.L@axisclinicals.com  
 
Details of Contact Person
Scientific Query  
Name  DrSubhra Lahiri 
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd 
Address  Axis Clinicals Limited,1-121/1 Miyapur, Hyderabad

Hyderabad
TELANGANA
500049
India 
Phone  8886221089  
Fax  04040408060  
Email  Subhra.L@axisclinicals.com  
 
Details of Contact Person
Public Query  
Name  DrSubhra Lahiri 
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd 
Address  Axis Clinicals Limited,1-121/1 Miyapur, Hyderabad

Hyderabad
TELANGANA
500049
India 
Phone  8886221089  
Fax  04040408060  
Email  Subhra.L@axisclinicals.com  
 
Source of Monetary or Material Support  
APL Research Center Aurobindo Pharma Limited Survey No -313, Bachupally Village, Qutubullapur Mandal, Hyderabad  
 
Primary Sponsor  
Name  Aurobindo Pharma Limited 
Address  Survey No -313, Bachupally Village, Qutubullapur Mandal, Hyderabad -500 090  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
AXIS Clinicals Ltd  1-121/1, Miyapur, Hyderabad-500049, Telangana 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajendra Someshwar Anand  Anand Multispecialty Hospital and Research Center  4th Floor, Clinical research department Sarthak Mall, Mahatma Mandir Road, Sargasan Cross Road, Gandhinagar
Gandhinagar
GUJARAT 		 9824017400

drrajendraanand@yahoo.com 
Dr Timir Kumar Chandrakant Shah  Divyam Hospital  2nd floor, Clinical research room,Block No.84, Palsana Cross Road, National Highway No.8, Palsana, Surat, Gujarat, 394315
Surat
GUJARAT 		 9825137443

drtcshah@gmail.com 
Dr Bakul buch  Shri Hatkesh Healthcare Foundation  2nd floor, Clinical research department, Shri Hatkesh Healthcare Foundation, Opposite 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 
Anand Ethics Committee  Approved 
Institutional Ethics Committee,Divyam Hospital  Approved 
Shri Hatkesh Healthcare Foundation Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F208||Other schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cariprazine Capsules 6 mg  Patients will be administered one capsule of Test or Reference once daily per orally from day 1 to day 14 in period-I and from day 15 to day 28 in period-II 
Comparator Agent  VRAYLAR (cariprazine) Capsules 6 mg  Patients will be administered one capsule of Test or Reference once daily per orally from day 1 to day 14 in period-I and from day 15 to day 28 in period-II 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male and female patient aged 18 to 65 Years (both inclusive) with body mass index between 18.5 to 30 kg/m2 (both inclusive)
2.Patient already receiving stable dose of Cariprazine 6 mg once daily for at least 04 weeks before screening only
3.Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder without psychotic features
OR
Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Schizophrenia
4.Patient having adequate hematologic reserve as per principal investigator assessment
5.Patient having adequate and stable hepatic and renal function as per principal investigator assessment at screening only
6.Patient should have no clinically significant abnormality in any of the laboratory parameters including ECG and Chest X-ray as per the discretion of Principal Investigator at screening only
7.Patient and Legally Acceptable Representative had given consent after being advised of the nature and risks of the study
8.Female patient of childbearing potential must have a negative serum pregnancy test
9.Females must use acceptable and effective methods of contraception such as the following:
•Tubal sterilization (tubal ligation performed more than one month before Study Day 1; transcervical tubal occlusion procedure performed more than six months before Study Day 1)
•Intrauterine Device (IUD)
•Progestin Implant (i.e. Implanon or its equivalent)
•Progestin injection or progestin oral contraceptive pill + one barrier method (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide + a male or female condom)
•Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide + a male or female condom)
•Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner) during the study and till 60 days post dose
10.Patient having normal physical examination, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal findings that are judged not clinically significant by the Principal Investigator (PI) at screening only
11.Patient having laboratory values as follows:
•Absolute neutrophil count (ANC) ≥1500/μL
•Hemoglobin (Hb) ≥ 9 g/dL
•Platelets ≥ 100,000/ μL
•AST or ALT must be < 3 x ULN
•Total bilirubin < 1.5 x the institutional ULN
•Creatinine ≤ 1.5 x ULN

 
 
ExclusionCriteria 
Details  1.Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 antipsychotic trials of an adequate duration (at least 6 weeks) and at a therapeutic dose range
2.Active suicidal or homicidal intent (as documented by informants or in the Investigator’s opinion) or a prior suicide or homicide attempt in the past 2 years
3.At imminent risk of injuring self or others or causing significant damage to property, as judged by the Investigator
4.Documented disease of the central nervous system that could interfere with the study assessments, including but not limited to stroke, tumor, Parkinson’s disease, organic brain disease, seizure disorder (except for febrile convulsions during infancy), chronic infection, or neurosyphilis; or patients who had suffered a traumatic brain injury resulting in significant impairment
5.Patient with history of clinically significant cardiovascular, renal, hepatic, respiratory, endocrine (except noninsulin-dependent diabetes mellitus), or gastrointestinal disease
6.Patient with known history of significant orthostatic hypotension (i.e., a drop in systolic blood pressure of at least 20 mm hg or more and / or a drop in diastolic blood pressure of at least 10 mm Hg or more on standing)
7.Patient with cataracts
8.Current or past history of tardive dyskinesia or neuroleptic malignant syndrome
9.Patient found to be positive for HIV and/or HBsAg and/or HCV at preliminary screening
10.Patient with history of epilepsy or seizures or are comatose or experiencing severe central nervous system depression
11.Patient is unable to communicate with the investigator
12.Patients with history of allergic reactions to Cariprazine or chemically related psychotropic drugs
13.Patient is smoker or alcoholic
14.Patient had history of difficulty with donating blood or difficulty in accessibility of veins
15.Patient consumed grape fruit/mosumbi/sweet lime juice within the 48 hours prior to study check-in
16.Female patient who is pregnant or currently breast-feeding
17.Females of child bearing potential unwilling to use acceptable contraception throughout the trial and for 14 days after the last dose of study drug
18.Patient participation in another clinical trial within the preceding 90 days of study starts
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cmax-ss-Maximum concentration over the steady state dosing interval.
AUC0-Ï„: Area under the blood concentration – time curve over the steady state dosing interval. 		 Venous blood samples 4 mL will be withdrawn 5 minutes prior to dosing on Day 12, 13 and 14 in Period I and Day 26, 27 and 28 Period II to confirm steady state condition. Day 1 predose sample will be collected to confirm that patients are on stable dose of Cariprazine.
Venous blood samples 4 mL will be withdrawn on Day 14 and 28 at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post drug administration.
 
 
Secondary Outcome  
Outcome  TimePoints 
Cmin-ss: Minimum concentration over the steady state dosing interval.
Cavg-ss: Average concentration over the steady state dosing interval.
Percentage fluctuation: [Cmax-ss – Cmin-ss/ Cavg-ss] X 100
Tmax-ss: Time of maximum measured blood concentration over the steady state dosing interval.
Cpd (pre-dose concentration)-Pre-dose concentrations determined before a dose at steady state.
Swing: [Cmax-ss-Cmin-ss/ Cmin-ss]
 		 Venous blood samples 4 mL will be withdrawn 5 minutes prior to dosing on Day 12, 13 and 14 in Period I and Day 26, 27 and 28 Period II to confirm steady state condition. Day 1 predose sample will be collected to confirm that patients are on stable dose of Cariprazine.
Venous blood samples 4 mL will be withdrawn on Day 14 and 28 at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post drug administration.
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="41" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/05/2019 
Date of Study Completion (India) 25/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a multicentric, open-label, randomized, two-treatment, two-sequence, two-period, cross-over, multiple dose, steady state, clinical bioequivalence study of Cariprazine Capsules 6 mg of Aurobindo Pharma Limited, India (Test) with VRAYLAR (Cariprazine) Capsules 6 mg of Allergan USA, Inc. Irvine, CA 92612, USA (Reference) in patients already receiving a stable dose of Cariprazine capsules 6 mg under fasting condition.

Patients will be titrated and clinically stabilized for at least 04 weeks to a dose of 6 mg of the reference product after preliminary screening. Patients who meet the requirements for study participation will be randomized. The hospital duration for each patient will be about 29 days.

The study will be planned to investigate bioequivalence of Aurobindo Pharma’s Test formulation with Reference formulation (T Vs R). Patients will receive allotted drug once daily from Day 1 to Day 14 and alternate study treatment as per randomization from Day 15 to Day 28 without washout period with 240 mL of water.

 
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