Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers

This is a Phase 1/2, randomized multiple treatments, single dose study assessing the
pharmacokinetics (PK) and absolute bioavailability of Fer-In-Sol ( Ferrous Sulfate) and
Triferic (ferric pyrophosphate citrate, or FPC) administered orally with Shohl's solution in
healthy volunteers.

Total participation in the study is approximately six weeks and is comprised of a screening
visit, 6 treatment periods, and a follow-up visit.

The study will be conducted over a 13 day period:

Day 1 will used to determine the baseline serum iron profile for each subject.

Each subject will subsequently receive in a randomized sequence between Day 2 and 10:

1. A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).

2. A single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed after
10 minutes by Fer-In-Sol at 3 mg Fe/kg bw

3. a single oral dose of Triferic PO at 3 mg Fe/kg bw

4. a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10
minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw.

5. a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed
immediately by a single oral dose of Triferic at 3 mg Fe/kg bw.

All subjects will receive a single dose of 6.6 mg Triferic as a 4 hour IV infusion (to mimic
the 4 hour iron tolerance test) on Day 12.

Blood samples will be obtained at various times to analyze for serum iron parameters and for
safety.

Inclusion Criteria:

1. The patient must be able to provide informed consent and have personally signed and
dated the study written informed consent document before completing any study-related
procedures.

2. The patient has hemoglobin, MCV and reticulocyte values within the reference range for
gender. (Male: Hgb ≥13.0 g/dL; Female Hgb ≥ 12.0 g/dL) at Screening.

3. The patient must have transferrin saturation (TSAT) of ≥20% at Screening.

4. The patient must have a total iron binding capacity (TIBC) of ≥250 ug/dL at Screening.

5. The patient must have a serum ferritin within the following reference range for gender
at Screening: (Males: 23-336 ng/mL; Females: 11-306 ng/mL).

6. The patient must agree to discontinue all iron preparations for 14 days prior to
Baseline.

7. If the patient is female, she must be non-pregnant and non-lactating, and be at least
90 days post-partum (if applicable) at Screening. Women of childbearing potential must
be willing to use appropriate birth control during the entire duration of the study.

8. The patient must be willing and able to comply with all study procedures and
restrictions.

9. The patient must have no clinically significant abnormal findings on medical history,
vital signs, physical examination, or clinical laboratory results during Screening.

10. The patient must have a body mass index (BMI) of ≤35.0 kg/m2 at Screening.

Exclusion Criteria:

1. The patient has had administration of oral iron supplements within 14 days prior to
Baseline.

2. The patient has received IV iron within 6 months prior to Screening.

3. The patient has a serum CRP concentration above the upper limit of normal at Screening
or Baseline (> 6.0 mg/L).

4. The patient has concurrent or recurrent disease (e.g., cardiovascular, renal, hepatic,
gastrointestinal, malignant, etc.) that could affect the action or disposition of the
investigational product utilized in this study, or could affect clinical or laboratory
assessments.

5. The patient has an acute illness within 14 days prior to Baseline.

6. The patient is currently using any medication (including prescription,
over-the-counter (OTC), herbal, or homeopathic preparations) within 14 days prior to
Baseline. Exceptions are contraceptives, hormone replacement therapy, acetaminophen,
and non-steroidal anti-inflammatory drugs.

7. The patient has known or suspected intolerance or hypersensitivity to iron-containing
products.

8. The patient has a history of alcohol or substance abuse within the past year.

9. The patient has a positive screen for cotinine or drugs of abuse.

10. The patient is positive for HIV, hepatitis B, or hepatitis C by history.

11. The patient donated blood or blood products (e.g., plasma or platelets) within 30 days
prior to Screening.

12. The patient has participated in an investigational drug study within 30 days prior to
Screening.

13. The patient is pregnant or intends to become pregnant before completing the study.

14. The patient's current medical status, in the investigator's opinion, would preclude
participation in the study.