A Multi-Center Relative Bioavailability Study of Azacitidine 75 mg/m2 Subcutaneous Injection In Myelodysplastic Syndrome Patients Under Fasting Conditions
This study is an open label, multi-center randomized, single dose, two-treatment,
two-period, two-sequence, two-way cross-over, relative bioavailability study of Azacitidine
for Injection for suspension use manufactured for Bioniche Pharma USA LLC compared with
Vidaza® manufactured by Celgene Corporation in MDS patients under fasting conditions.
Patients who are on a stable 75 mg/m2 dose of Vidaza will be randomized to study drug
sequence Azacitidine on C1D1/ Vidaza® on C2D1 or Vidaza® on C1D1 / Azacitidine on C2D1.
Randomization will be in a 2:2 ratio. Thirty-six (36) patients will be enrolled to ensure
28 evaluable patients. Patients will not be blinded to their treatment assignment.
After randomization, fasted patients will receive 1 dose of assigned study drug (either
Azacitidine for Injection or Vidaza®) subcutaneously at a dose of 75 mg/m2 on C1D1. On
Days 2-7, they will receive their normal Vidaza® treatment. Following a 21 day rest period,
patients will cross over to receive the alternate treatment on C2D1 followed by their normal
Vidaza®) treatment on Cycle 2 Days 2-7. The Final Patient Visit will be conducted 7 days
following the last dose of Vidaza®.
The total duration of the study for each patient will be up to 56 days including the
Screening period and Post Study Visit.
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Measurement of Azacitidine in Plasma Samples for Determination of Cmax, AUC0-t, and AUC0-Inf
Pharmacokinetic samples will be collected pre-dose and at 12 timepoints post-dose for determination of the level of azacitidine. The relative bioavailability of test to reference drug will be evaluated. If the Cmax, AUC0-t and AUC0-inf 90% confidence intervals for the geometric mean ratio all lie within 80-125% for Azacitidine then bioequivalence is concluded.
13 timepoints from pre-dose to 8 hours post dose
Pierre FENAUX, MD Professor
Service d'hématologie clinique- Hôpital Avicenne
United States: Food and Drug Administration
|Holy Cross Hospital||Fort Lauderdale, Florida 33308|
|Wilshire Oncology Medical Group||Glendora, California 91741|
|Pacific Cancer Medical Center Inc.||Anaheim, California 92801|
|California Cancer Associates||Fresno, California 93720|