Conditions: Myelodysplastic Syndrome Myelofibrosis Chronic Myeloid Leukemia Chronic Lymphocytic Leukemia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 38
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.

Detailed description:
To assess the bioequivalence of Vidaza® and Luitpold Azacitidine pharmacokinetics, in terms of Maximal Concentration (Cmax), Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t), and Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞), following SC administration.

To assess the comparative safety of Vidaza® versus Luitpold Azacitidine during the 2 day study period.

Arms:
arm 1: Participants first received Luitpold Azacitidine subcutaneously (SC) on Day 1. After a washout period of 24 hours, they then received Vidaza on Day 2. arm 2: Participants first received Vidaza subcutaneously (SC) on Day 1. After a washout period of 24 hours, they then received Luitpold Azacitidine on Day 2.

Interventions: intervention 1: Luitpold Azacitidine intervention 2: Vidaza®
Intervention descriptions: intervention 1: Subcutaneous (SC) at a dose of 75 mg/m\^2 per day on days 1 and 2 of a treatment cycle intervention 2: Subcutaneous (SC) at a dose of 75 mg/m\^2 per day on days 1 and 2 of a treatment cycle

Protocol document: