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

NCT01290302 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-06-12

Study results available
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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.

Conditions

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

Sponsors & Collaborators

  • American Regent, Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph Perno, MD,PhD · Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-22
Primary Completion
2012-12-31
Completion
2012-12-21

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290302 on ClinicalTrials.gov