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CTRI Number  CTRI/2014/02/004385 [Registered on: 07/02/2014] Trial Registered Prospectively
Last Modified On: 17/07/2014
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of imatinib mesylate tablets in patients of chronic myeloid leukemia and gastrointestinal stromal tumor 
Scientific Title of Study   A Randomized, Open Label, Two-Treatment, Multiple Dose, Steady State, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Imatinib Mesylate Tablet 400 mg of Amneal Pharmaceuticals, USA with GLEEVEC® (Imatinib Mesylate) Tablet 400 mg Distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in Adult Patients Suffering from Chronic Myeloid Leukemia & Gastrointestinal Stromal Tumor under Fed Conditions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ARL/CT/13/001 V00 Amendment 00 dated 16-Dec-2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashutosh Jani 
Designation  Asst. GM, Clinical Trials 
Affiliation  Accutest Research Laboratories (I) Pvt. Ltd. 
Address  Opposite The Grand Bhagwati Hotel, Sarkhej Gandhinagar Highway, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  0917940231612  
Fax  0917940029317  
Email  ashutosh.jani@accutestindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Agam Shah 
Designation  Medical Expert - Clinical Trials 
Affiliation  Accutest Research Laboratories (I) Pvt. Ltd. 
Address  Opposite The Grand Bhagwati Hotel, Sarkhej Gandhinagar Highway, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  0917940231612  
Fax  0917940029317  
Email  agam.shah@accutestindia.com  
 
Details of Contact Person
Public Query  
Name  Mr Prasann Bavania 
Designation  Project Manager 
Affiliation  Accutest Research Laboratories (I) Pvt. Ltd. 
Address  Opposite The Grand Bhagwati Hotel, Sarkhej Gandhinagar Highway, Ahmedabad

Ahmadabad
GUJARAT
380054
India 
Phone  0917940231607  
Fax  0917940029317  
Email  prasann.bavania@accutestindia.com  
 
Source of Monetary or Material Support  
Amneal Pharmaceuticals, LLC 
 
Primary Sponsor  
Name  Amneal Pharmaceuticals LLC 
Address  85, Adams Avenue 48, Hauppauge, NY 11788, USA 
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 = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mukul Goyal  Apex Hospital Private Limited  Oncology Department, Apex Hospital Private Limited, SP-4 & 6, Malviya Industrial Area, Malviya Nagar, Jaipur- 302017
Jaipur
RAJASTHAN 		 0141-2233337

drmukulgoyal@yahoo.in 
Dr Satya Suresh Attili  BIBI General Hospital and Cancer Centre  16-3-991/1/C, Govt. Printing Press Road, Malakpet, Hyderabad- 500024
Hyderabad
ANDHRA PRADESH 		 040-24528122

sureshattili@yahoo.com 
Dr Rajnish Nagarkar  Curie Manavata Cancer Centre  Opp.Mahamarg Bus Stand, Mumbai Naka, Nashik - 422004
Nashik
MAHARASHTRA 		 9823061929

drrajnagarkar@yahoo.co.in 
Dr K N Srinivasan  Dr.G.Viswanathan Speciality Hospitals  Department of Oncology, Dr.G.Viswanathan Speciality Hospitals, 27, Babu Road, Trichy - 620008
Tiruchirappalli
TAMIL NADU 		 0431-3031234

kns68@yahoo.com 
Dr Niraj Bhatt  Kailash Cancer Hospital & Research Centre  Muni Seva Ashram, Goraj- 391760, Waghodia
Vadodara
GUJARAT 		 0912668-268041
0912668-268048
medonc12@gmail.com 
Dr Yathishkumar H M  Karnataka Cancer Hospital & Research Centre  No-99, Jharakabande kaval, Krishnadanagar, Nandim layout, Bangalore, 560096
Bangalore
KARNATAKA 		 9880462912

dryathish@hotmail.com 
Dr Sandip Bartakke  Lokmanya multispeciality hospital  Department of Oncology, Lokmanya multispeciality hospital, Tilak Rd, Sector No. 24, Nigdi, Pimpri, Chinchwad, Pune
Pune
MAHARASHTRA 		 9763164057

spbartakke@rediffmail.com 
Dr Pinakin Patel  Manu Hospital & Research Centre  Oncosurgery, Manu Hospital & Research Centre, A-1,Shyam Nagar, Sodala, Jaipur-302019
Jaipur
RAJASTHAN 		 982983814

drpinakinp@gmail.com 
Dr Ananda Selvakumar Pandy  Meenakshi Mission Hospital and Research Centre  Radiation Oncology, Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai- 625107
Madurai
TAMIL NADU 		 0452-2588741

drassk81@yahoo.co.in 
Dr Shibashish Bhattacharya  Nightingale hospital  Oncology Department, 11, Shakespeare Sarani, Kolkata - 700071
Kolkata
WEST BENGAL 		 9051837235

shibashishbhattacharya@ymail.com 
Dr Madhuchanda kar  Peerless Hospital & B.K. Roy Research Centre Ltd  Medical Oncology, Peerless Hospital & B.K. Roy Research Centre Ltd, 360 Panchasayar, Kolkata - 700 094
Kolkata
WEST BENGAL 		 033-24622394

madhuchandakar@yahoo.com 
Dr K C Lakshmaiah  Srinivasam Cancer Care Hospitals India Private Limited  236/1,Vijayashree Layout, Arekere, Bannerghatta Main Road, Bangalore-560076
Bangalore
KARNATAKA 		 04223261222

kcluck@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
BIBI Institutional Ethics Committee  Approved 
Clinical Research Ethics Committee, Peerless Hospital and B.K. Roy Research Centre  Approved 
Ethical Committee of Lokmanya Medical Research Centre  Approved 
Hospital Ethics Committee, Dr.G.Viswanathan Speciality Hospital  Approved 
Institutional Ethics Committee Apex Hospital Privte Limited  Approved 
Institutional Ethics Committee Manu Hospital & Research Centre  Approved 
Institutional Ethics Committee Nightingale Hospital  Submittted/Under Review 
Institutional Ethics Committee Srinivasam Cancer Care Hospital  Approved 
Institutional Ethics Committee, Karnataka Cancer Hospital & Research Centre  Approved 
Kailash Cancer Hospital and Medical Centre Institutional Ethics Committee  Approved 
Manavata Clinical Research Institute Ethics Committee  Submittted/Under Review 
Meenakshi Mission Hospital & Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Myeloid Leukemia and Gastrointestinal Stromal Tumor,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GLEEVEC® (imatinib mesylate) tablet 400 mg distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936  Patient will be administered oral dose of one tablet with approximately 240 mL of water at ambient temperature in sitting position, under observation, at approximately 30 minutes of starting standardized breakfast after fasting for at least 10 hrs daily for 7 days 
Intervention  Imatinib mesylate tablet 400 mg of Amneal Pharmaceuticals, USA  Patient will be administered oral dose of one tablet with approximately 240 mL of water at ambient temperature in sitting position, under observation, at approximately 30 minutes of starting standardized breakfast after fasting for at least 10 hrs daily for 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  2. Diagnosed case of Philadelphia chromosome positive (Ph+) CML or GIST and presently being treated with imatinib 400 mg tablets.
3. Willing to give written informed consent for participation in the trial as well as willing and able to comply with study visit schedule and other protocol requirements.
4. Female patients of child bearing potential (except for those who have completed one year since menopause or have been hysterectomized) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing and must agree to use effective contraception (barrier or hormonal) for the study period. 
 
ExclusionCriteria 
Details  The Patients with any of the following criteria should be excluded.
1. History of hypersensitivity to imatinib mesylate or to any of the excipients as judged by investigator.
2. Patient of CML receiving treatment in Myeloid Blast Crisis or Accelerated Phase
3. Abnormal laboratory results as below,
• Absolute neutrophils count less than 1000/ mm3
• Platelet Count less than 50,000/mm3
• SGOT and/or SGPT greater than 5 times upper limit of normal (ULN)
• Serum total Bilirubin greater than 3 times ULN
• Serum TSH greater than 10 microIU/mL
• Serum Uric Acid greater than 12 mg/dL
• Reactive for HIV antibody, HBsAg or HCV antibody
4. History of a heart failure, renal insufficiency, hypereosinophilic syndrome (HES), myelodysplastic syndrome (MDS)/ myeloproliferative disease (MPD) or acute systemic mastocytosis (ASM).
5. History of therapy with any of the following as per timelines before randomization,
• Inducers of CYP3A4 activity within 14 days
• Inhibitors of CYP3A4 activity within 14 days.
• Investigational product/ device within last one month
6. Alcohol or any drug dependence within past one year.
7. Blood donation/ loss exceeding 200 ml within last 60 days. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess biequivalence of intervention product compared to comparator product at steady state pharmacokinetics under fed conditions  Blood sampling will be done from predose to untill 24 hours after the dosing on day 7 and day 14 of the study 
 
Secondary Outcome  
Outcome  TimePoints 
Safety and tolerability of intervention product compared to comparator product by adverse events  Throughout the study from dosing till follow up on day 22 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Imatinib mesylate a selective inhibitor of BCR-ABL kinase activity, has demonstrated significant clinical efficacy in the treatment of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST) producing durable responses and prolonged survival such that it has become the standard of care for these diseases. Imatinib has favorable pharmacokinetic (PK) characteristics, including rapid and complete oral bioavailability (nearly 98%) and a proportional dose-exposure relationship. Its terminal half-life is approximately 20 hours, allowing for once daily dosing.

Amneal Pharmaceuticals, LLC (Amneal) has developed generic version of imatinib mesylate tablets EQ 400 mg base. The present study aims to evaluate bioequivalence of Amneal’s test formulation against corresponding reference product GLEEVEC® (imatinib mesylate) tablet 400 mg distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in adult patients, who are diagnosed to have CML or GIST and are presently being treated with imatinib oral tablets.

Primary objective: To characterize pharmacokinetic profile of test product – Imatinib Mesylate tablet EQ 400 mg base of Amneal Pharmaceuticals, LLC, compared to that of the corresponding reference product – GLEEVEC® (imatinib mesylate) tablet 400 mg distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in adult patients, who are diagnosed to have CML or GIST and are presently receiving stable dose of imatinib mesylate tablets 400 mg, and assess their bioequivalence.

Secondary Objective: To monitor the safety and tolerability of a multiple doses of Imatinib Mesylate Tablets EQ 400 mg base in adult patients, who are diagnosed to have CML or GIST and are presently receiving stable dose of Imatinib Mesylate tablets 400 mg.
 
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