Health Condition 1: C920- Acute myeloblastic leukemia
Conditions
Interventions
Intervention1: Azacitidine Tablets 300mg: During each of the study periods, patients will receive a single oral dose with 150 mL of water.
Control Intervention1: ONUREG (Azacitidine) 300mg: During eac
Sponsors
PLIVA Croatia Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients of 18 years of age and above at the time of signing the informed consent form. 2. Able to understand and voluntarily sign an informed consent form prior to any study related assessments and procedures. 3. Patients with documented diagnosis of acute myeloid leukemia who achieved complete remission or complete remission with incomplete blood count recovery following induction chemotherapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation. 4. Patients who are scheduled to be initiated on maintenance therapy with azacitidine tablets 300mg or already on a stable dose of azacitidine tablets 300mg (for these patients a washout period of 14 days to be maintained prior to the dosing in period I). 5. As per investigator discretion, patients must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population. 6. Have an Eastern Cooperative Oncology Group performance status of 0-2, inclusively. 7. Have a life expectancy of more than 3 months based on the clinical judgement of the Investigator. 8. Have stable renal function without dialysis for at least 2 months prior to Investigational Medicinal Product administration. 9. Have adequate bone marrow function at the screening and randomization visits. 10. Have adequate hepatic function at the screening visit. 11. Have a 12-lead Electrocardiogram with no clinically significant findings at screening, as determined by the investigator. 12. Women of childbearing potential must be non-pregnant or non-lactating. 13. Able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Gastrointestinal tumors, tumors that have originated or metastasized to the liver, or other tumors known to interfere with the absorption, distribution, metabolism, or excretion of drugs. 2. Patients requiring any concurrent chemotherapy, hormonal therapy, immunotherapy, therapy with biologicals or radiotherapy for the disease. 3. Have been treated with an investigational agent within 4 weeks prior to the first day of IMP administration. 4. Patients treated with proton pump inhibitors like esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole. 5. A positive test result for HIV, HBsAg and HCV. 6. Have ongoing clinically significant adverse event(s) due to prior treatments administered as determined by the investigator 7. Significant active cardiac disease within the previous 6 months. 8. Have known or suspected hypersensitivity to azacitidine or any other ingredient used in the manufacturing of azacitidine. 9. Uncontrolled systemic fungal, bacterial, or viral infection. 10. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 11. Any condition that confounds the ability to interpret data from the study. 12. Impaired ability to swallow oral medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the bioequivalence between Test product Azacitidine 300mg tablets and Reference product ONUREG® (Azacitidine) 300mg tablets in patients with Acute Myeloid LeukemiaTimepoint: Day 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor safety & tolerability 1) Adverse events 2) Laboratory abnormalities 3) Clinical signs & Symptoms 4) Laboratory parametersTimepoint: Day 2 | — |
Countries
India
Contacts
Public ContactDr Shailendra Sachan
Teva pharm India Pvt. Ltd
Outcome results
None listed