| CTRI Number |
CTRI/2014/12/005332 [Registered on: 30/12/2014] Trial Registered Prospectively |
| Last Modified On: |
21/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A bioequivalence study of Imatinib Mesylate Tablets 400 mg of Intas Pharmaceuticals Limited, India to the reference listed drug Gleevec® (Imatinib Mesylate) Tablets 400 mg in patients of Chronic Myeloid Leukaemia (CML) |
|
Scientific Title of Study
|
A multicentre, randomized, open label, steady state, two treatment, two period, two-way crossover, bioequivalence study under fed conditions comparing Imatinib Mesylate Tablets 400 mg of Intas Pharmaceuticals Limited, India to the reference listed drug Gleevec® (Imatinib Mesylate) Tablets 400 mg of Novartis Pharma Stein AG, Stein, Switzerland for Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in patients of Philadelphia chromosome positive Chronic Myeloid Leukaemia (CML), stabilized on Imatinib Mesylate 400 mg |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 651-13, Version 01, 05 Aug 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajit Solanki |
| Designation |
Ass. Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court, S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202097 |
| Fax |
07940202021 |
| Email |
ajitsolanki@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Ranpura |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court, S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202074 |
| Fax |
07940202021 |
| Email |
ankitranpura@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Shetty |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court, S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202098 |
| Fax |
07940202098 |
| Email |
praveenshetty@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas Pharmaceuticals Limited. |
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Limited |
| Address |
2nd Floor, Chinubhai Centre, Ashram Road,Ahmedabad-380009, Gujarat. India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Lambda Therapeutic Research Ltd |
Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad-380061, Gujarat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayanti G Patel |
Apple Hospital |
Department of Medical Oncology, Room no. 1, Udhna Darwaja, Ring Road-395002
Surat
GUJARAT |
9825121347
pateldrjayanti@gmail.com |
| Dr Gururaj Deshpandey |
City Cancer Centre |
Department of Oncology, 33-25-33, Ch. Venkata Krishnayya Street, Suryarao Pet, Vijaywada-520002
Krishna
ANDHRA PRADESH |
9603548495
mgopichand@yahoo.com |
| Dr Rajnish Vasant Nagarkar |
Curie Manavata Cancer Centre |
Department of Oncology, Room No-1,Opp. Mahamarg, Bus Stand, Mumbai Naka-422004
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Jitendra Kumar Singh |
S.S. Hospital and Research Centre |
Department of Oncology, Doctors Colony, Malahi Pakri Chowk, Kankarbagh-800020
Patna
BIHAR |
9431021001
drjksingh147@hotmail.com |
| Dr T M Suresh |
Srinivasam Cancer Care Hospitals India Pvt. Ltd. |
Department of Radiology, No. 236/1, Vijayashree Layout, Arekere, Bannnerghatta Main Road-560076
Bangalore
KARNATAKA |
9901917427
kcluck@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Apple Hospital Ethics Committee, |
Approved |
| Institutional Ethics Committee, City Cancer Centre |
Submittted/Under Review |
| Institutional Ethics Committee, S.S. Hospital and Research Centre |
Submittted/Under Review |
| Manavata Clinical Research Institute Ethics Committee |
Submittted/Under Review |
| Srinivasam Cancer Care Hospitals - IEC |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C921||Chronic myeloid leukemia, BCR/ABL-positive, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gleevec®, Novartis Pharma |
Dose-400 mg,Frequency-daily, Mode of Administration-Oral, Duration of treatment-7 days |
| Intervention |
Imatinib Mesylate, Intas Pharmaceuticals Limited |
Dose-400 mg,Frequency-daily, Mode of Administration-Oral, Duration of treatment-7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients able to give informed consent for participation in the trial.
2.Male or female patients must be 18 to 65 years of age (both inclusive) at the screening visit.
3.Patients of Philadelphia chromosome positive Chronic Myeloid Leukemia
4.Patient should be able to comply with study procedures in the opinion of the investigator.
5.Male or Female patient must agree to use an effective measures of Contraception during the study |
|
| ExclusionCriteria |
| Details |
1.Known hyper sensitivity to Imatinib or any of its excipients or related group of drugs.
2.Patients with known human immunodeficiency virus (HIV) infection.
3.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
4.Use of any recreational drugs or history of drug addiction.
5.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
6.Any other condition or abnormal baseline findings that, in the investigator’s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To characterize the pharmacokinetic profile of the sponsor’s test formulation (Imatinib Mesylate Tablets 400 mg) relative to that of reference formulation (Gleevec® (Imatinib Mesylate) Tablets 400mg) in chronic myeloid leukemia patients and to assess the bioequivalence. |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the patients exposed to the Investigational Medicinal Product. |
Before and at the end of the study |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
02/03/2015 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Imatinib mesylate (Imatinib) is a selective inhibitor of the protein tyrosine kinase associated with bcr-abl and specifically inhibits proliferation of Ph expressing cells. To prevent healthy volunteers from adverse events and as per Guidance on the conduct of bioequivalence study with Imatinib Mesylate3, this study is proposed to be carried out on patients of Chronic Myeloid Leukaemia (CML). In this study, Imatinib Mesylate Tablets 400 mg or Gleevec® (Imatinib Mesylate) Tablets 400 mg will be administered to patients at an interval of 24 hr for 14 days Following oral administration, the elimination half-life of Imatinib and its major active metabolite, the N-demethyl derivative, are approximately 18 and 40 hours, respectively. Therefore, this steady state multiple dose study will be performed in patients of Chronic Myeloid Leukaemia (CML). |