clinical trial · NCT06326697
Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)
Acute Myeloid LeukaemiaAzacitidineOnureg
brief summary
A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated Tablets in adult patients with AML under fasting conditions
started
May 2, 2024
primary completion
Aug 17, 2025
completion
Aug 28, 2025
last updated
Sep 26, 2025
official title
A Randomized, Single Oral Dose, Open Label, Two Sequence, Two Treatment, Four Periods, Full Replicate Crossover Study to Determine the Bioequivalence of Azacitidine 300 mg Film- Coated Tablets Versus Onureg® 300 mg Film-Coated Tablets for Adult Patients With Acute Myeloid Leukaemia (AML) Under Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol