Health Condition 1: null- Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Conditions
Interventions
Intervention1: Imatinib Mesylate 400mg: Dose-400mg, Frequency-Once Daily, Route of Administration-Oral, Total Duration of Therapy-5 Days
manufactured by Hetero Labs Limited, India
Control Intervention
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject and /or LAR or impartial witness able to give written informed consent for participation in the trial. 2. Male or female subjects should be 18-65 (both inclusive) years of age at the screening visit. 3. Body mass index of 18-30 kg/m2 (both inclusive) 4. Subjects of Chronic Myeloid Leukemia in chronic phase with documented evidence of Philadelphia chromosome positive (Ph+ CML). 5. Subject should be on stable dose of Imatinib Mesylate 400 mg tablets for whom a titration away from the 400 mg dose is unlikely. 6. Subject should have an ECOG performance status of 0-2. 7. Subject should have an adequate bone marrow, renal and hepatic function Body system Parameters: Body system Parameters Bone marrow function ANC >= 1500/mm3, Platelet count >= 100,000/mm3 Hemoglobin >= 9.0 g/dl Renal function Serum Creatinine Hepatic function Total Bilirubin ALT/AST Alkaline phosphatase 8. Subject should be able to comply with study procedures in the opinion of the investigator. 9. Women of childbearing potential must have a negative pregnancy test at screening. 10. Women with child bearing potential and men with reproductive potential should be willing to practice acceptable methods of birth control during the study, and 4 weeks post-last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Known Hypersensitivity to the Imatinib class of drugs or to any of the excipients of Imatinib tablets. 2. Subjects with known human immunodeficiency virus (HIV) infection. 3. A positive hepatitis screen including hepatitis B surface antigen and HCV. 4. Subjects of Ph+ CML in Accelerated Phase (AP) or Blast Crisis (BP). 5. Previous/current history of hematopoietic stem cell transplantation. 6. Subject is on drugs known to be inducer or inhibitor of CYP3A4 family. 7. Subject who have undergone Thyroidectomy. 8. A known history of significant bleeding disorder unrelated to CML. 9. Use of any recreational drugs or history of drug addiction. 10. History of blood loss (approximately 1 U) 90 days prior to screening. 11. Any other condition or abnormal findings that, in the investigatorâ??s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. 12. Subject with a history of difficulty in donating blood or difficulty in accessibility of veins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate pharmacokinetic bioequivalence of Imatinib Mesylate 400mg immediate release tablet manufactured by Hetero Labs Limited, India, versus Gleevec® 400mg tablet manufactured by Novartis under steady state, fed conditionsTimepoint: To demonstrate pharmacokinetic bioequivalence of Imatinib Mesylate 400mg immediate release tablet manufactured by Hetero Labs Limited, India, versus Gleevec® 400mg tablet manufactured by Novartis under steady state, fed conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of Imatinib Mesylate 400mg immediate release tablets manufactured by Hetero Labs Limited, India compared to Gleevec® 400mg tablets manufactured by NovartisTimepoint: During the study | — |
Countries
India
Contacts
Public ContactDr Chinnababu Sunkavalli
Clinsync Clinical Research Pvt. Ltd.
Outcome results
None listed