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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)

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 - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/12/005332
Enrollment
42
Registered
2014-12-30
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, Intas Pharmaceuticals Limited: Dose-400 mg,Frequency-daily, Mode of Administration-Oral, Duration of treatment-7 days Control Intervention1: Gleevec®, Novartis Pharm

Sponsors

Intas Pharmaceuticals Limited
Lead Sponsor
Lambda Therapeutic Research Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

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.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 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.

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 chronic myeloid leukemia patients and to assess the bioequivalence.Timepoint: 14 Days—

Secondary

MeasureTime frame
To monitor the safety of the patients exposed to the Investigational Medicinal Product.Timepoint: Before and at the end of the study—

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