Table 1.
Baseline‐Corrected Pharmacokinetic Parameters for sFetot in Healthy Volunteers After Intravenous Administration of Ferric Pyrophosphate Citrate Iron
| FPC Iron Dose (mg) 4‐Hour Intravenous Infusion | FPC Iron Dose (mg) 12‐Hour Intravenous Infusion | |||||||
|---|---|---|---|---|---|---|---|---|
| Pharmacokinetic Parametera | 0 | 2.5 | 5.0 | 7.5 | 10.0 | 0 | 15.0 | 20.0 |
| Cmax, μg/dL | 62.6 (32.4) | 113 (44.5) | 151 (33.9) | 228 (19.7) | 261 (30.3) | 44.3 (34.8) | 177 (38.2) | 251 (51.7) |
| λz, 1/h | – | 0.5 (0.1) | 0.7 (0.3) | 0.7 (0.4) | 0.9 (0.7) | – | 0.5 (0.3) | 0.3 (0.1) |
| t½app, hours | – | 1.3 (0.2) | 1.2 (0.5) | 1.3 (0.7) | 1.0 (0.5) | – | 1.9 (1.1) | 2.2 (0.6) |
| CL, dL/h | – | 4.1 (1.2) | 5.1 (1.0) | 4.6 (0.5) | 5.6 (0.9) | – | 6.7 (1.6) | 6.6 (1.5) |
| tmax, hoursb | – | 4.9 | 4.3 | 4.8 | 4.3 | – | 8.5 | 7.8 |
| AUC0‐t, μg · hr/dL | – | 675 (270) | 1010 (190) | 1650 (172) | 1840 (263) | – | 2340 (565) | 3150 (657) |
AUC0‐t, area under the serum concentration‐time curve from 0 to the time of the last quantifiable concentration; CL, total drug clearance; Cmax, maximum serum concentration; FPC, ferric pyrophosphate citrate; λz, terminal rate constant; sFetot, serum total iron; t½app, apparent terminal‐phase half‐life; tmax, time to maximum serum concentration.
a
Values are expressed as mean (SD) unless otherwise indicated.
b
Median value.