Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer

This study has been completed.
Sponsor:
Information provided by:
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00719459
First received: July 15, 2008
Last updated: October 8, 2010
Last verified: October 2010
  Purpose

The primary objective of this study is to assess the bioequivalence of the test product Hospira Iron Sucrose 20 mg/mL (Hospira, Inc.) to the reference product Venofer® 20 mg/mL following intravenous administration to healthy subjects.


Condition Intervention Phase
Healthy Volunteers
Drug: Iron Sucrose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Single-Dose, Parallel-Design, Bioequivalence Study of Hospira Iron Sucrose Injection Compared to Venofer Injection USP in Healthy Subjects.

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: PK sampling at various times ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Hospira Iron Sucrose
Drug: Iron Sucrose
Iron sucrose 20 mg/mL
Active Comparator: 2
Venofer
Drug: Iron Sucrose
Venofer 20 mg/mL

Detailed Description:

Iron is essential to the synthesis of hemoglobin (Hb) to maintain oxygen transport and to the function and formation of other physiologically important heme and nonheme compounds. Iron deficiency may be caused by blood loss during dialysis, increased erythropoiesis following administration of epoetin, and insufficient absorption of iron from the gastro-intestinal tract. Most dialysis patients require intravenous iron supplementation to replenish iron stores.

Iron sucrose is used to replenish body iron stores in patients with iron deficiency on chronic hemodialysis and receiving erythropoietin. In these patients iron deficiency is caused by blood loss during dialysis procedure, increased erythropoiesis, and insufficient absorption of iron from the gastrointestinal tract. Most hemodialysis patients require intravenous iron to maintain sufficient iron stores to achieve and maintain a hemoglobin level of 11-12 g/dL.

Subjects who fulfill the inclusion/exclusion criteria after screening will be randomized to receive 100 mg of iron sucrose as either Hospira Iron Sucrose or Venofer®.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female volunteers between 18 and 55 years of age (both inclusive).
  2. Having a Body Mass Index (BMI) between 18.5 and 32.0 kg/m2 (both inclusive).
  3. If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing birth control:
  4. Must have, in the investigator's opinion, no abnormal laboratory evaluations taken at Screening visit or admission to the Phase 1 unit on Day -1.
  5. Must be a non-smoker (defined as a subject who has not smoked for 3 months) and agree to abstain from alcohol for 24 hours prior to each dosing treatment and while a resident in the treatment unit.
  6. Able to provide written informed consent after risks and benefits of the study have been explained.
  7. Able to communicate effectively with study personnel.

Exclusion Criteria:

  1. Documented bleeding disorders, acute bleeding or recently documented hemorrhage.
  2. Any disease or condition that might interfere with the absorption, distribution, metabolism, or excretion of the study drug or would place the subject at increased risk.
  3. History of drug abuse or alcohol abuse within 2 years of study enrollment as determined by the investigator or a positive urine drug test prior to Day -1.
  4. Use of any prescription medicine within 14 days prior to start of the study, or over the counter medications or herbal remedies within 3 days prior to study entry (vitamins or calcium supplements allowed, except iron supplements).
  5. Use of iron supplements within 3 months of the start of the study.
  6. A subject with anemia (hemoglobin < 8 mg/dL).
  7. Relative or absolute iron deficiency or iron overload.
  8. Clinically significant medical or psychiatric illness currently or within 30 days of study entry as determined by investigator.
  9. Significant drug sensitivity or a significant allergic reaction to any drug.
  10. Known hypersensitivity or idiosyncratic reaction to iron sucrose injection or any other related drugs.
  11. A positive result at screening for HIV, Hepatitis B or C.
  12. A subject who has been administered an injectable drug within 14 days prior to the start of the study.
  13. A subject who has donated or lost 475 mL (i.e., 1 pint) or more blood volume (including plasmaphoresis) or had a transfusion of any blood product within 3 months prior to the initial study drug administration.
  14. Current participation or participation within 30 days prior to the initial study drug administration in a drug or other investigational research study.
  15. A subject who may not be able to comply with the safety monitoring requirements of this clinical trial or is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00719459

Locations
United States, Missouri
Bio-Kinetic Clinical Applications
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

Responsible Party: Islah Ahmed, MD, Hospira, Inc.
ClinicalTrials.gov Identifier: NCT00719459     History of Changes
Other Study ID Numbers: IRON-07-04, 24 April 2008 Final
Study First Received: July 15, 2008
Last Updated: October 8, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ferric oxide, saccharated
Ferric Compounds
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014