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CTRI Number  CTRI/2013/11/004137 [Registered on: 12/11/2013] Trial Registered Prospectively
Last Modified On: 13/11/2013
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Other 
Public Title of Study   Compare bioavailability of Asenapine Maleate EQ 10mg base tablet with SAPHRIS® EQ 10mg base of Merck Sharp &Dohme Corp.a subsidiary of Merck&Co IN. Whitehouse Station,NJ08889, USA in patients with Schizophrenia and manic or mixed episodes associated with bipolarI disorder as monotherapy. 
Scientific Title of Study   A multicenter, open label, randomized, balanced, two treatment, three period, three sequence, reference-scaled, multiple dose, comparative oral bioavailability study of Asenapine Maleate EQ 10 mg base sublingual tablet Manufactured by Watson Pharma Pvt. Ltd., India with SAPHRIS® ( Asenapine Maleate tablets) sublingual tablets EQ 10 mg base of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IN., Whitehouse Station, NJ 08889, USA in adult human patients with Schizophrenia and manic or mixed episodes associated with bipolar I disorder under Fasting steady-state condition. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Brijesh Wadekar  
Designation  Head of Department  
Affiliation  Veeda Clinical Research Pvt. Ltd.  
Address  Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road, Bodakdev Road, S.G.highway. Ahmedabad

Ahmadabad
GUJARAT
380059
India 
Phone  07930013001  
Fax  079300013010  
Email  brijesh.wadekar@veedacr.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Brijesh Wadekar  
Designation  Head of Department  
Affiliation  Veeda Clinical Research Pvt. Ltd.  
Address  Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road, Bodakdev Road, S.G.highway. Ahmedabad

Ahmadabad
GUJARAT
380059
India 
Phone  07930013001  
Fax  079300013010  
Email  brijesh.wadekar@veedacr.com  
 
Details of Contact Person
Public Query  
Name  Dr Brijesh Wadekar  
Designation  Head of Department  
Affiliation  Veeda Clinical Research Pvt. Ltd.  
Address  Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road, Bodakdev Road, S.G.highway. Ahmedabad

Ahmadabad
GUJARAT
380059
India 
Phone  07930013001  
Fax  079300013010  
Email  brijesh.wadekar@veedacr.com  
 
Source of Monetary or Material Support  
Watson Pharma Pvt. Ltd. 
 
Primary Sponsor  
Name  Watson Pharma Pvt Ltd 
Address  Unit V International Technology Centre, CBD Belapur Railway Station Complex, Navi Mumbai – 400 614, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPrasad rao  Asha Hospital  #298, Road No. 14, Banjara Hills, Hyderabad 500034, India
Hyderabad
ANDHRA PRADESH 		 040-66752222

prasad40@gmail.com 
DrR Mahajan  Dayanand Medical College & Hospital  Department of Psychiatry, third floor , Ludhiana-141001, Punjab
Ludhiana
PUNJAB 		 01612300643

ranjive@gmail.com 
Dr Timir Shah  Divyam Hospital  32, Maher Park-A, Athwa Gate, Surat, Gujarat,
Surat
GUJARAT 		 02612470870

divyamhospital@gmail.com 
Dr Dharmesh Patel  L. G. Hospital  AMC MET Medical College and Sheth L.G. General Hospital, Maninagar, Ahmedabad-380008
Ahmadabad
GUJARAT 		 07926608485

dr1dharmesh1patel@yahoo.co.in 
DrKaustubh  Ruby Hall Clinic  40, sassoon road, pune , 411001
Pune
MAHARASHTRA 		 9881769500

kaustubhjoag@gmail.com 
DrB S V Prasad  Sujata Birla Hospital & Medical Research Centre  Opp. Bytco College , Nasik Pune Highway Nasik Road, Nasik-422101, Maharashtra, India
Nashik
MAHARASHTRA 		 09822039737

bsvprasad2@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
AMC MET Ethics Committee/Ahmedabad/Dr.Dharmesh Patel  Approved 
Divyam Hospital Ethical Review Board /Surat/Dr. Timir Shah  Approved 
Drug Trial Ethics committee/Ludhiana/Dr.R. Mahajan  Submittted/Under Review 
Ethics Committee Asah Hospital/Hyderabad/Dr.Prasad rao  Submittted/Under Review 
Institutional Ethics Coomittee, Poona Medical Research foundation/Pune/Dr.Kaustubh  Approved 
Yash Society Ethics Committee/Nasik/Dr.B S V prasad  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with Schizophrenia and manic or mixed episodes associated with bipolar I disorder. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Asenapine Maleate   Asenapine Maleate EQ 10 mg base sublingual tablet twice daily, orally Manufactured by Watson Pharma Pvt. Ltd., India 
Comparator Agent  SAPHRIS®   SAPHRIS® ( Asenapine Maleate tablets)EQ 10 mg base sublingual tablets,twice daily, orally of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IN., Whitehouse Station, NJ 08889, USA  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Men and women, 18 years of age or older.
2.Ability to provide informed consent prior to participation in the study.
3.Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception.

4.Adequate organ function, defined as the following:
total bilirubin < 1.5 x upper limit of normal (ULN)
SGOT and SGPT < 2.5 x ULN,Creatinine < 1.5 x ULN
Platelets > 100 x 10 raise to 9 /L
5.No history of addiction to any recreational drug or drug dependence
6.No participation in any clinical study within the past 60 days.
7.Clinically acceptable ECG in opinion of an Investigator.  
 
ExclusionCriteria 
Details  1.A history of allergic or adverse reactions to asenapine maleate or any comparable or similar product
2.A history of severe hepatic impairment, drug induced leukopenia/neutropenia, congenital prolongation of the QT interval, cardiac arrhythmias, myocardial infarction or unstable heart disease
3.Concurrent primary psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson’s disease
4.A total white blood cell count below 4000/cmm, or an absolute neutrophil count below 2000/cmm
5.A history of granulocytopenia or myeloproliferative disorders (drug-induced or idiopathic)
6.Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing)
7.Concurrent use of antihypertensive medication or any medication that might predispose to orthostatic hypotension
8.A medical or surgical condition that might interfere with the absorption, metabolism, or excretion of asenapine maleate
9.A history of epilepsy or risk for seizures
10.Concurrent use of other drugs known to suppress bone marrow function
11.Expected changes in concomitant medications during the period of study
12.Positive tests for drug or alcohol abuse at baseline
13.A history of alcohol or drug dependence by Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria during the 6-month period immediately prior to study entry
14.Compliance with outpatient medication schedule not expected
15.History of multiple syncopal episodes
16.Patients who are:
•Pregnant
•Breast feeding
•Of childbearing potential without a negative pregnancy test prior to baseline
•Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial
•Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
•Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
•Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
17.Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
18. Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure, neuropsychiatric infection or disease.
19.History of difficulty with donating blood or difficulty in accessibility of veins.
20.An unusual or abnormal diet, for whatever reason e.g. religious fasting. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare and evaluate the multiple-dose oral bioavailability of Asenapine Maleate EQ 10 mg base sublingual tablet Manufactured by Watson Pharma Pvt. Ltd., India with SAPHRIS® ( Asenapine Malate tablets) sublingual tablets EQ 10 mg base of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IN., Whitehouse Station, NJ 08889, USA in adult human patients with Schizophrenia and manic or mixed episodes associated with bipolar I disorder as monotherapy under Fasting steady-state condition   The pre-dose blood sample on Day 5, 6, 7 12, 13, 14, 19, 20 and 21 will be collected 3.0 ml within 5 minutes before dosing time. On day 7, 14 and 21, the post-dose blood samples of 3.0 mL each will be drawn at 0.5, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00 hrs following drug administration in each period.  
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to ensure the safety of Patient  NA 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   02/12/2013 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a multicenter, open label, randomized, balanced, two treatment, three period, three sequence,  reference-scaled, multiple dose, comparative oral bioavailability study of Asenapine Maleate EQ 10 mg base  sublingual tablet Manufactured by  Watson Pharma Pvt. Ltd., India with SAPHRIS® ( Asenapine Maleate tablets) sublingual tablets  EQ 10 mg base of  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IN., Whitehouse Station, NJ 08889, USA in adult human patients with Schizophrenia and manic or mixed episodes associated with bipolar I disorder  under Fasting steady-state condition. The study duration for each subject will be of 22 days. Patients should be appropriate candidates for asenapine maleate sublingual tablet, EQ 10 mg base twice daily therapy and have been taking a stable dose of asenapine maleate sublingual tablet, EQ 10 mg base twice daily therapy for at least three months will be eligible for the study.   
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