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

Not Applicable

Completed

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

Registration Number: CTRI/2013/07/003836

Lead Sponsor: Ranbaxy Laboratories Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 42

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

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.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 (GleevecÂ® 400 mg tablets) in adult patients of philadelphia chromosome positive chronic myeloid leukemia stabilized with Imatinib mesylate 400 mgTimepoint: PK sample- <br/ ><br>0.500,3.000,5.000,20.000

Secondary Outcome Measures