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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, single dose, two treatment, two period, two sequence, crossover, bioequivalence study under fed conditions comparing of Imatinib Mesylate 400 mg tablets (Ranbaxy Laboratories Limited, India) to the reference listed drug Gleevec® (Imatinib Mesylate) Tablets 400 mg (Novartis Pharmaceuticals Corporation, East Hanover, New Jersey-07936) in patients of Philadelphia chromosome positive Chronic Myeloid Leukaemia stabilized on Imatinib Mesylate tablets 400mg

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/07/003836
Enrollment
42
Registered
2013-07-24
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 orally on Day 01 and Day 08 Control Intervention1: Gleevec® (Imatinib Mesylate): 400 mg OD orally on Day 01 and Day 08

Sponsors

Ranbaxy Laboratories Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient 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 on stable dose of Imatinib Mesylate 400 mg tablets. 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 Hypersensitivity to the active substance or to any of the excipients of Imatinib tablets. 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.If the patient have previously undergone hematopoietic stem cell transplantation. 6.Significant bleeding disorder unrelated to CML. 7.Use of any recreational drugs or history of drug addiction. 8.Any other condition or abnormal baseline findings that, in the investigatorâ??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. 9.Patient with a history of difficulty in donating blood or difficulty in accessibility of veins.

Design outcomes

Secondary

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

Primary

MeasureTime frame
To characterize the pharmacokinetic profile and assess bioequivalence of the sponsorâ??s test formulation (Imatinib Mesylate 400 mg tablets) relative to that of reference formulation (Gleevec® 400 mg tablets) in adult patients of philadelphia chromosome positive chronic myeloid leukemia stabilized with Imatinib mesylate 400 mgTimepoint: PK sample- 0.500,3.000,5.000,20.000—

Countries

India

Contacts

Public ContactDr Praveen Shetty

Lambda Therapeutic Research Ltd,

ankitranpura@lambda-cro.com07940202074

Outcome results

None listed

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