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.