Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

November 22, 2010

Primary Completion Date

December 31, 2012

Study Completion Date

December 21, 2012

Conditions
Myelodysplastic SyndromeMyelofibrosisChronic Myeloid LeukemiaChronic Lymphocytic Leukemia
Interventions
DRUG

Luitpold Azacitidine

Subcutaneous (SC) at a dose of 75 mg/m\^2 per day on days 1 and 2 of a treatment cycle

DRUG

Vidaza®

Subcutaneous (SC) at a dose of 75 mg/m\^2 per day on days 1 and 2 of a treatment cycle

Trial Locations (1)

19403

Luitpold Pharmaceuticals, Inc., Norristown

Sponsors
All Listed Sponsors
lead

American Regent, Inc.

INDUSTRY

NCT01290302 - Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza | Biotech Hunter | Biotech Hunter