Trials / Completed
CompletedNCT01290302
Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza
Blinded Cross-over Bioequivalence Trial of Luitpold Azacitidine Versus Vidaza® in Patients With Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia or Chronic Lymphocytic Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- American Regent, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2010-11-22
- Primary completion
- 2012-12-01
- Completion
- 2012-12-21
- First posted
- 2011-02-07
- Last updated
- 2025-06-12
- Results posted
- 2025-05-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01290302. Inclusion in this directory is not an endorsement.