Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive
Conditions
Interventions
Intervention1: Imatinib Mesylate Tablets 400 mg of CSPC Pharmaceutical Co., Ltd, China: Dose: 400 mg,
Frequency: everyday,
Mode of Administration: oral,
Duration of treatment: 7 days
Control Interv
Sponsors
CSPC Pharmaceutical Co Ltd
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. Patient must be on stable dose of 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. 7. Patient should be able to comply with study procedures in the opinion of the investigator. 8. In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 1 (before dosing) must be negative. 9. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. 10. In case of Male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. It is investigatorâ??s responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol.
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. Patient is on drugs known to be inducer or inhibitor of CYP3A4 family. 7. Patient who have undergone Thyroidectomy. 8. Use of any recreational drugs or history of drug addiction. 9. 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. 10. 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. 11. The receipt of an investigational medicinal product within a period of 30 days prior to the first dose of investigational medicinal Product for the current study. 12. Patient with a history of difficulty in donating blood or difficulty in accessibility of veins. 13. Patient with history of Hepatotoxicity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize and compare 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 mg and to assess the bioequivalence after multiple dose administration under fed conditions.Timepoint: Day 1 to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patients exposed to the Investigational Medicinal Product.Timepoint: Day 1 to Day 14 | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Lambda Therapeutic Research Ltd
Outcome results
None listed