Health Condition 1: null- Adult Patients Suffering from Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor under Fed Conditions Health Condition 2: C921- Chronic myeloid leukemia, BCR/ABL-positive
Conditions
Interventions
Intervention1: Imatinib mesylate tablets is 400 mg: 400 mg once a day for 7 Days
Control Intervention1: Gleevec®(Imatinib Mesylate) Tablet 400 mg: 400 mg once a day for 7 Days
Sponsors
Qilu Pharmaceutical Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 to 55 years (both inclusive) and either sex. 2.Diagnosed case of Philadelphia chromosome positive (Ph+) CML patients in chronic phase or GIST and presently being treated with imatinib 400 mg tablets 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0â??2. 4.Willing to give written informed consent for participation in the study as well as willing and able to comply with study visit schedule and other protocol requirements. 5.Patientâ??s screening laboratory assessments are clinically non-significant as per the discretion of the Investigator. 6.Female patients of child bearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing, must be non-lactating at screening and must agree to use effective contraception (barrier or hormonal) for the study period.
Exclusion criteria
Exclusion criteria: 1.History of hypersensitivity to imatinib mesylate or to any of the excipients as judged by investigator. 2.Patient of CML receiving treatment in Myeloid Blast Crisis or Accelerated Phase The Patients with any of the following criteria should be excluded: 3.Abnormal laboratory results as below: Absolute neutrophils count Platelet Count SGOT &/or SGPT > 5 times upper limit of normal (ULN) Serum total Bilirubin > 3 times ULN Serum TSH > 10 μIU/mL Serum Uric Acid > 12 mg/dL Reactive for HIV antibody, HBsAg or HCV antibody 4.History of a heart failure, renal insufficiency, hypereosinophilic syndrome (HES), myelodysplastic syndrome (MDS)/ myeloproliferative disease (MPD) or acute systemic mastocytosis (ASM). 5.Alcohol or any drug dependence within past one year. 6.Blood donation/ loss exceeding 200 mL within last 60 days. 7.History of therapy with any of the following as per timelines before randomization: Inducers of CYP3A4 activity within 14 days Inhibitors of CYP3A4 activity within 14 days. Investigational product/ device within last one month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize pharmacokinetic profile of test product â?? Imatinib Mesylate tablets compared to that of the corresponding reference productâ?? gleevec® (imatinib mesylate) tablets 400 mg who are diagnosed to have CML or GIST and are presently receiving stable dose of imatinib mesylate tablets 400 mg, and assess their bioequivalence.Timepoint: On days 5 and 12, 1st pre-dose blood sampling within 10 minutes before IP dose will be done On days 6 and 13, 2nd pre-dose blood sampling within 10 minutes before IP dose will be done On days 7 and 14, 3rd pre-dose sample will be taken within 10 minutes before IP dose and thereafter post dose sampling will be done at 00.25, 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 08.00, 10.00, 12.00, 16.00, and 24.00 hrs post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of a multiple doses of imatinib mesylate tablets 400 mg in adult patients, who are diagnosed to have CML or GIST and are presently receiving stable dose of imatinib mesylate tablets 400 mg.Timepoint: Monitoring and Reporting of Adverse Events. | — |
Countries
India
Contacts
Public ContactDr Hiren Gandhecha
Accutest Research Laboratories (I) Pvt Ltd
Outcome results
None listed