findmyKOL
Clinical trialNCT01152346CompletedPhase 1Interventional

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

SponsorBioniche Pharma USA LLCEnrollment19Myelodysplastic Syndrome
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

France
  • Service D'Hématologie Clinique Hôpital Avicenne

    Bobigny, France

  • Chu de Brest- Hôpital Morvan

    Brest, France

  • Centre Hospitalier Lyon Sud

    Lyon, France

  • Hôpital Archet 1

    Nice, France

  • Hôpital Haut-Lévêque

    Pessac, France

  • Ch Annecy

    Pringy, France

  • Chu Purpan

    Toulouse, France

  • Centre Régional de Cancérologie Henry-Kaplan Service D'Hématologie Et Thérapie Cellulaire

    Tours, France

  • Service D'Hématologie Et de Médecine Interne Chu de Nancy Hôpital de Brabois

    Vandœuvre-lès-Nancy, France

United States
  • Pacific Cancer Medical Center Inc.

    Anaheim, California, United States

  • Wilshire Oncology Medical Group

    Corona, California, United States

  • California Cancer Associates

    Fresno, California, United States

  • Holy Cross Hospital

    Fort Lauderdale, Florida, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Azacitidine for InjectionVidaza®
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Apr 2011
Primary completion
31 Dec 2012
Completion
31 May 2013
Last update posted
28 Jan 2015
Registered enrollment
19
Registry id
NCT01152346

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.