Spots Global Cancer Trial Database for Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)
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Trial Identification
Brief Title: Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)
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
Study ID: NCT06326697
Conditions
Study Description
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
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
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