FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/10/007398 [Registered on: 24/10/2016] Trial Registered Prospectively
Last Modified On: 24/01/2020
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study   Pharmacokinetic Equivalence 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence Study Of Imatinib Mesylate Tablets 400 mg Of Cadila Healthcare Ltd., India And ‘Gleevec’ (Imatinib Mesylate) Tablets 400 mg Of Novartis Pharmaceuticals Corporation, USA In Patients With Gastrointestinal Stromal Tumors Or Chronic Myeloid Leukemia Under Fed Conditions. 
Scientific Title of Study   An Open-Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Multiple Dose, Steady-State, Crossover, Multicentre, Bioequivalence Study Of Imatinib Mesylate Tablets 400 mg Of Cadila Healthcare Ltd., India And ‘Gleevec’ (Imatinib Mesylate) Tablets 400 mg Of Novartis Pharmaceuticals Corporation, USA In Patients With Gastrointestinal Stromal Tumors Or Chronic Myeloid Leukemia Under Fed Conditions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRL071518, Version 1.0 , dated 04 Sep 2015  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrCharu Gautam 
Designation  Associate VP Global Clinical Operation 
Affiliation  Cliantha Research Ltd 
Address  Sigma 1 Corporate Off SG Highway Bodakdev Ahmedabad Gujarat Cliantha House Opp Pushparaj Tower Near Judges Bungalow Road Bodakdev Ahmadabad GUJARAT

Ahmadabad
GUJARAT
380054
India 
Phone  07966219555  
Fax  07966219549  
Email  cgautam@cliantha.in  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Ankesh Barnwal 
Designation  Sr. Medical Monitor 
Affiliation  Cliantha Research Limited 
Address  Cliantha Research Limited Garden View Corporate House no. 8, 3rd floor, Opp AUDA Garden,Bodakdev- AHmedabad-380054

Ahmadabad
GUJARAT
380054
India 
Phone  079-66219545  
Fax  07966219549  
Email  abarnwal@claintha.in  
 
Details of Contact Person
Public Query  
Name  Dr Chirag Shah 
Designation  Head Clinical Trials 
Affiliation  Cliantha Research Ltd 
Address  Sigma 1 Corporate Off SG Highway Bodakdev Ahmedabad Gujarat Cliantha House Opp Pushparaj Tower Near Judges Bungalow Road Bodakdev Ahmadabad GUJARAT

Ahmadabad
GUJARAT
380054
India 
Phone  07966219531  
Fax  07966219549  
Email  cshah@cliantha.in  
 
Source of Monetary or Material Support  
Cadila Healthcare Limited 
 
Primary Sponsor
Modification(s)  
Name  Cadila healthcare Ltd 
Address  Cadila healthcare Ltd Sarkhej – Bavla N.H. No. 8A Vill: Moraiya, Tal: Sanand Dist: Ahmedabad - 382210 Gujarat, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajnish Nagarkar  Curie Manavata Cancer Centre  OPD, Ground Floor, Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik-422004, Maharashtra, India
Nashik
MAHARASHTRA 		 919970184510
0253-2594866
drtejashree@mcrinasik.com 
Dr M Gopichand  Department of Oncology City Cancer Centre  Clinical Reseaerch Room City Cancer Center, 33-25-33, CH. Venkata krishnayya street suryarao pet, Vijayawada-520002, AndhraPradesh, India
Hyderabad
ANDHRA PRADESH 		 9885256059
0866-2430871
mgopichand@yahoo.com 
Dr Guruprasad Mohanty  Kailash Cancer Hospital and Research Center   1st floor, Muni Seva Ashram, P.O. Goraj-391760, Tal.Waghodia, Dis.Vadodara, Gujarat, India
Vadodara
GUJARAT 		 09427432383
02668-268048
guru.prasad@greenashram.org 
DrYadav Amod Eknath   Lifepoint Multispeciality Hospital  Clinical Research Dept 3rd Floor 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune- 411057, Maharashtra, India
Pune
MAHARASHTRA 		 91-09890196118
020-66434300
yadav.amod57@gmail.com 
Dr Kirushna Kumar   Meenakshi Mission Hospital & research Centre  Department of Radiation Oncology, Ground Floor, Lake area, Melur Road, Madurai- 625017, Tamilnadu, India
Madurai
TAMIL NADU 		 919787713004
0452-258-6353
drkskk@yahoo.com 
Dr KCLakshmaiah  Srinivasam Cancer Care Hospital India Pvt.Ltd  236/1, Vijayashree layout, Arekere, Bannerghatta main Road, Banglore-560076, Karnataka
Bangalore
KARNATAKA 		 91-9448055949
8042099074
kcluck@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Ethics Committee Meenakshi Mission Hospital & research Centre  Approved 
Institutional Ethics Committee, City Cancer Centre  Approved 
Kailash Cancer Medical Center Institutional Ethics Committee   Approved 
LPR Ethics Committee Lifepoint Multispeciality Hospital  Approved 
Manavata Clinical Research Institute Ethics committee  Approved 
Srinivasam Cancer care Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  GASTROINTESTINAL STROMAL TUMORS OR CHRONIC MYELOID LEUKEMIA UNDER FED CONDITIONS.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GLEEVEC’ (Imatinib Mesylate) Tablets 400 mg OD Oral for 8 days  Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 
Intervention  Imatinib Mesylate Tablets 400 mg OD Oral for 8 days  Manufactured by: Cadila Healthcare Ltd., India. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  79.00 Year(s)
Gender  Both 
Details 
1) Patients must be receiving stable doses of Imatinib (i.e. 400 mg once a day) for the treatment of Gastrointestinal Stromal Tumors or Chronic Myeloid Leukemia.
2) Males or non pregnant or non lactating females of age ≥ 18 years and ≤ 79 years.
3) Life expectancy of at least 3 months.
4) Having ECOG status ≤ 2
5) Patients willing to not change their concurrent medications during the study.
6) All patients should have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 18.
7) Able to comply with Protocol requirements and assessments
8) Able to give written informed consent to participate in the study
 
 
ExclusionCriteria 
Details  • Patients presenting with any of the following will be excluded from the study:
• History of allergic responses to Imatinib Mesylate, or other related drugs and any of its formulation ingredients.
• Patients receiving concomitant therapy of warfarin (coumarin anticoagulants) or history of usage of coumarin anticoagulants in the previous three months prior to study start (dosing).
• Major surgery to the gastrointestinal tract, the liver or kidney within 4 weeks of study entry which may impact on the pharmacokinetics of Imatinib.
• History of difficulty in swallowing, or any gastrointestinal disease which could affect drug absorption.
• Patients with cardiac disease or risk factors for cardiac failure.
• Patients with prior History of erythema multiforme or Stevens-Johnson syndrome
• Patients with History of Hypothyroidism or currently suffering from Hypothyroidism.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cmax,ss, AUCtau, Tmax,ss, Cmin,ss,Cav,ss, degree
of Fluctuation and swing will be calculated for Imatinib
 		 0.25 hrs, 0.5 hrs, 1.0 hrs, 1.5 hrs, 2.0 hrs, 2.5 hrs, 3.0 hrs, 3.5 hrs, 4.0 hrs, 4.5 hrs, 5.0 hrs, 5.5 hrs, 6.0 hrs, 8.0 hrs, 12.0 hrs, 16.0 hrs
 
 
Secondary Outcome  
Outcome  TimePoints 
Safety and Adverse events.  NA 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/10/2016 
Date of Study Completion (India) 06/02/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
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   This is an open-label, randomized, two-period, two-treatment, two-sequence, multiple-dose, steady-state, cross-over, multicentre, pharmacokinetic bioequivalence study in patients with Gastrointestinal Stromal Tumors or Chronic Myeloid Leukemia under fed conditions. 
Close