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Bioequivalence Study of Azacitidine for Injection in Myelodysplastic Syndrome (MDS) Patients

NCT01152346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2015-01-28

No results posted yet for this study

Summary

The purpose of the study is to determine the bioavailability of Azacitidine for Injection relative to Vidaza® in MDS patients under fasting conditions. The data will be evaluated statistically to determine if the products meet bioequivalence criteria.

Conditions

Interventions

DRUG

Azacitidine for Injection

75 mg/m2 sc injection on Day 1 of either cycle 1 or cycle 2 per randomization assignment

DRUG

Vidaza®

75 mg/m2 sc injection on Day 1 of either cycle 1 or cycle 2 per randomization assignment

Sponsors & Collaborators

  • Bioniche Pharma USA LLC

    lead INDUSTRY

Principal Investigators

  • Pierre FENAUX, MD Professor · Service d'hématologie clinique- Hôpital Avicenne

  • Emmanuel GYAN, MD · Centre régional de cancérologie Henry-Kaplan Service d'Hématologie et thérapie cellulaire-Hôpital Bretonneau

  • Agnès-Paule GUERCI-BRESLER, MD · Service d'hématologie et de médecine interne-Hôpital de Brabois

  • Jean-Richard Eveillard, MD · CHU de Brest- Hôpital Morvan

  • Odile BEYNE-RAUZY, MD Professor · University Hospital, Toulouse

  • Laurence LEGROS, MD · Hôpital Archet 1

  • Mauricette MICHALLET, MD Professor · Hôpital Edouard Herriot

  • Krimo Bouabdallah, MD · Hôpital Haut-Lévêque

  • Pascal Cony-Makhoul, MD · CH Annecy

  • Manjesh Lingamurthy, MD · Holy Cross Hospital

  • Steven Hager, MD · California Cancer Associates

  • Misagh Karimi, MD · Wilshire Oncology Medical Group

  • Veena Charu, MD · Pacific Cancer Medical Center Inc.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-12-31
Completion
2013-05-31

Countries

  • United States
  • France

Study Locations

More Related Trials

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 NCT01152346 on ClinicalTrials.gov