Health Condition 1: - Health Condition 2: C920- Acute myeloblastic leukemia
Conditions
Interventions
Intervention1: Azacitidine Tablets: Dose: 300 mg,
Frequency: 1 tab twice a day,
Route of Administration: Oral,
Duration: Three days
Control Intervention1: ONUREG (Azacitidine): Dose: 300 mg,
Frequency
Sponsors
Watson Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients more than 18 years of age at the time of signing the informed consent form. 2. Understand and voluntarily sign an informed consent form prior to any study related assessments-procedures are conducted. 3. Patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy with or without consolidation chemotherapy and who are not eligible for hematopoietic stem cell transplantation. 4. 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. 5. Patients with a history of treated central nervous system involvement should be clinically stable for more than 4 weeks prior to signing the informed consent. Glucocorticoid therapy for central nervous system edema is permitted if less than 20 mg per day of prednisolone or equivalent. 6. Have an Eastern Cooperative Oncology Group performance status of 0-2, inclusively. 7. Have a life expectancy of more than 3 months. 8. Have stable renal function without dialysis for at least 2 months prior to Investigational Product. 9. Have adequate bone marrow function at the screening and randomization visits 10. Have a 12-lead Electrocardiogram with no clinically significant findings at screening, as determined by the investigator. 11. Women of child bearing potential must be non-pregnant or non-lactating. 12. 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. Patients requiring any concurrent chemotherapy, hormonal therapy, immunotherapy, therapy with biologicals or radiotherapy for the disease any previous aforementioned treatments within 4 weeks of period 1 dosing. 2. Have been treated with an investigational agent within 4 weeks prior to the first day of IP administration 3. Patients treated with proton pump inhibitors like esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole within 4 weeks prior to start of IMP or require as concomitant medication. 4. A positive test result for any of the following- HIV, Hepatitis B surface antigen, Hepatitis C, VDRL, drugs of abuse and breath alcohol test during check-in. 5. Have ongoing clinically significant adverse events due to prior treatments administered as determined by the investigator. 6. Significant active cardiac disease within the previous 6 months, including 7. Have known or suspected hypersensitivity to azacitidine or any other ingredient used in the manufacturing of Azacitidine. 8. Uncontrolled systemic fungal, bacterial, or viral infection defined as ongoing signs-symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and-or other treatment. 9. History of inflammatory bowel disease e.g. Crohns disease, ulcerative colitis, celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the study drug and-or predispose the subject to an increased risk of gastrointestinal toxicity. 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® (Azacititine) 300mg tablets in patients with Acute Myeloid LeukemiaTimepoint: 8 hours after dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor safety and tolerability Timepoint: Day 4 after first dose | — |
Countries
Bulgaria, Georgia, Germany, India, Slovakia
Contacts
Public ContactDr Shailendra Sachan
Teva pharm India Pvt. Ltd
Outcome results
None listed