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Sponsored by: |
Hospira, Inc. |
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Information provided by: | Hospira, Inc. |
ClinicalTrials.gov Identifier: | NCT00719459 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study |
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. |
Estimated Enrollment: | 60 |
Study Start Date: | June 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Hospira Iron Sucrose
|
Drug: Iron Sucrose
Iron sucrose 20 mg/mL
|
2: Active Comparator
Venofer
|
Drug: Iron Sucrose
Venofer 20 mg/mL
|
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®.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hospira, Inc. ( Islah Ahmed, MD ) |
Study ID Numbers: | IRON-07-04, 24 April 2008 Final |
Study First Received: | July 15, 2008 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00719459 |
Health Authority: | United States: Institutional Review Board |
Ferric oxide, saccharated Ferric Compounds Healthy Iron |
Hematinics Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Hematologic Agents Trace Elements Micronutrients Pharmacologic Actions |