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

drug protocol number

HIK-AZA-2023-01

drug sponsor

Hikma Pharmaceuticals

drug study

Azacitidine 300 mg Film- Coated Tablets

drug trial site

King Faisal Specialist Hospital and Research Center (Riyadh), King Abdulaziz Medical City NG (Riyadh), King Fahad Specialist Hospital (Dammam)

drug status

Ongoing

drug phase