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Comparison of two Imatinib Mesylate tablets in patients of Philadelphia chromosome positive Chronic Myeloid Leukaemia,stabilized on Imatinib Mesylate tablets 400mg

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 Dr. Reddyâ??s Laboratories 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. - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/004026
Enrollment
32
Registered
2013-09-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive

Interventions

Intervention1: Imatinib Mesylate Tablets: 400 mg OD daily orally for 14 days Control Intervention1: Gleevec® (Imatinib Mesylate) Tablets: 400 mg OD daily orally for 14 days

Sponsors

Dr Reddys Laboratories Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient and /or LAR or impartial witness able to give written informed consent for participation in the trial. 2. Male or female patients must be >= 18 years of age at the screening visit. 3. Patient must be stabilised with Imatinib Mesylate 400 mg for at least 30 days prior to dosing. 4. Patients of Chronic Myeloid Leukemia in chronic phase with documented evidence of Philadelphia chromosome positive (Ph+ CML). 5. Patient must have an ECOG performance status of 0-2. 6. Patient must have an adequate bone marrow, renal and hepatic function

Exclusion criteria

Exclusion criteria: 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. Patients of Ph+ CML in Accelerated Phase (AP) or Blast Crisis (BP). 5. Have previously undergone hematopoietic stem cell transplantation. 6. Use of any recreational drugs or history of drug addiction. 7. Any other condition or abnormal baseline findings that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. 8. Patient with a history of difficulty in donating blood or difficulty in accessibility of veins

Design outcomes

Primary

MeasureTime frame
To characterize the pharmacokinetic profile of the sponsorâ??s test formulation (Imatinib Mesylate Tablets 400 mg) relative to that of reference formulation (Gleevec® (Imatinib Mesylate) Tablets 400mg) in adult philadelphia chromosome positive chronic myeloid leukemia patients stabilized with Imatinib mesylate 400 mgTimepoint: PK sample 0.500, 1.000,1.500—

Secondary

MeasureTime frame
To monitor the safety of the patients exposed to the Investigational Medicinal Product.Timepoint: End of study—

Countries

India

Contacts

Public ContactDr Praveen Shetty

Lambda Therapeutic Research Ltd

ankitranpura@lambda-cro.com917940202074

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026