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Clinical trial

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

NCT06326697 is registered in ClinicalTrials.gov with Hikma Pharmaceuticals LLC as lead sponsor.

NCT NCT06326697
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Hikma Pharmaceuticals LLC
Phase
Phase 1
Overall status
Completed
Start date
May 2, 2024
Completion date
August 28, 2025
Enrollment
32 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

acute myeloid leukaemia