Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)

Inclusion Criteria

• •1. Patients age ≥ 18 years of age at the time of signing the informed consent document.
• •2. Patients with documented diagnosis of AML according to the 2022 updates of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukaemia.
• •3. Patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. The definitions of response criteria for CR or CRi are primarily those defined by the 2022 report from the European Leukemia Net (ELN) on AML as below: CR defined as bone marrow blasts \<5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥ 1.0 × 10\^9/L (1,000/µL); platelet count ≥ 100 × 10\^9/L(100 000/µL).
• •CRi defined as all CR criteria, except for residual neutropenia \< 1.0 × 10\^9/L (1,000/µL) or thrombocytopenia \< 100 × 10\^9/L (100 000/µL).
• •4. Patients who don't have a known or suspected hypersensitivity to Azacitidine or any other ingredient used in the manufacturing of Azacitidine.
• •5. Patients who are physically able for appropriate pharmacokinetics sampling according to principal investigator evaluation.
• •6. Patients who have a haematological profile appropriate for receiving Azacitidine 300 mg dose for 4 consecutive days as per the principal investigator assessment.
• •7. Patients who understand and voluntarily sign a written informed consent document prior to any study related assessments/procedures are conducted.
• •8. Patient is capable of consent.
• •9. Females of childbearing potential may participate, providing the subject meets the following conditions: Negative serum pregnancy test at screening (sensitivity of at least 25 mIU/mL), and willing to use effective contraception during and up to 6 months after study.
• •10. Male patients must be willing to use effective contraception during and up to 3 months after the study.