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

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®.

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:

- hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months
prior to study drug administration

- intrauterine device (IUD)

- double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring
with spermicidal jellies or cream).

If hormonal contraceptives are used, the specific contraceptive must have been used
for at least 3 months prior to study drug administration. If the subject is currently
using a hormonal contraceptive, she should also use a barrier method during this
study and for 1 month after study completion.

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.