This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours
An open-label, randomized, four period sequential study of Triferic AVNU administered intravenously by three different administration schedules compared to continuous infusion over 3 hours
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
Orlando Clinical Research Center
Orlando, Florida, United States
Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D
Time frame: 8 hours
Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D
Time frame: 8 hours
Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D
Time frame: 8 hours
Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D
Time frame: 8 hours
Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D
Time frame: 8 hours
Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D
Time frame: 8 hours
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