A Multi-Center Relative Bioavailability Study of Azacitidine 75 mg/m2 Subcutaneous Injection In Myelodysplastic Syndrome Patients Under Fasting Conditions

Inclusion Criteria:

- Male or female patients with age >18 years.

- Patients with Myelodysplastic Syndrome (MDS) placed on Vidaza® according to the
Marketing Authorization issued in the country in which the clinical study is being
conducted (i.e., in the US, patients with any of the following
French-American-British ( FAB) subtypes: Refractory Anemia (RA), Refractory Anemia
with Ringed Sideroblasts (RARS), (if accompanied by neutropenia or thrombocytopenia
or requiring transfusions), Refractory Anemia with Excess Blasts (RAEB), Refractory
Anemia with Excess Blasts in Transformation (RAEB-T) and Chronic Myelomonocytic
Leukemia (CMMoL); in France, subjects who are not eligible for hematopoietic stem
cell transplantation: with intermediate -2 and high-risk myelodysplastic syndromes
according to the International Prognostic Scoring System (IPSS) or chronic
myelomonocytic leukemia (CMML) with 10-29% marrow blasts without myeloproliferative
disorder) and who currently receive Vidaza at 75 mg/m2;

- Patient life expectancy > 6 months.

- Patients with performance status of 0 - 2 as per ECOG Scale.

- Patients with Total Bilirubin < 1.5 x ULN; ALT/AST < 2 x ULN, Serum Creatinine < 1.5
ULN, Serum Bicarbonate > 19 mEq/L.

- Patients who have signed the Informed Consent Form.

Exclusion Criteria:

- Patients with a history of alcoholism or drug addiction (during past 2 years)

- Patients with severe hepatic impairment, impaired renal function, and any condition
which in the Investigator's opinion would be contraindicated or would interfere with
absorption of the study drug.

- Patients whose clinical laboratory test values are outside the reference range may be
re-tested at the discretion of the Investigator. If the clinical values are outside
the range on re-testing, the patient will not be eligible to participate in the study
unless the Investigator deems the result not to be significant.

- Patients with any other active malignancy within the past 5 years except for
cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma
of the skin.

- Patients who have a history of allergic responses to the class of drug being tested.

- Patients with hypersensitivity to Mannitol.

- Patients should not have donated blood and/or plasma for at least thirty (30) days
prior to the first dosing of the study drug. Patients should not have had any
transfusion of blood products for at least 7 days prior.

- Patients who have taken any investigational drug within thirty (30) days prior to the
first dosing of the study.

- Female patients who are pregnant, breast-feeding, or who are likely to become
pregnant during the study. Female patients of child bearing potential will be
instructed to either abstain from sexual intercourse or use an acceptable method of
birth control during the course of the study and for 3 months afterward. Male
patients or their female partners should also use an acceptable method of birth
control.

- Any patient whom the Investigator believes will not be a good candidate for the
study.