At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 38 enrolled
Drug / intervention
Luitpold Azacitidine +1 moredrug
Likely dose
Luitpold Azacitidine 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Blinded Cross-over Bioequivalence Trial of Luitpold Azacitidine Versus Vidaza® in Patients With Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia or Chronic Lymphocytic Leukemia
In Brief
A Phase 1 clinical trial evaluating Luitpold Azacitidine and Vidaza® for Myelodysplastic Syndrome and 3 related conditions. Completed, enrolled 38 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedFeb 2011
Primary CompletionDec 2012
Study CompletionDec 2012
TodayJul 2026
First PostedFeb 7, 2011
Enrollment StartNov 22, 2010
Primary CompletionDec 1, 2012
Study CompletionDec 21, 2012
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 15.4 years ago
Interventions
Luitpold Azacitidinedrug
Subcutaneous (SC) at a dose of 75 mg/m\^2 per day on days 1 and 2 of a treatment cycle
Vidaza®drug
Subcutaneous (SC) at a dose of 75 mg/m\^2 per day on days 1 and 2 of a treatment cycle