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:~A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).~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~a single oral dose of Triferic PO at 3 mg Fe/kg bw~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.~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.
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study.