drugset / Trial / NCT02767128

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

NCT02767128

Phase 1 Completed 14 enrolled Rockwell Medical Technologies, Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2016-04
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferrous Sulfate Diagnostic / imaging agent 3 mg/kg Oral
Subject Triferic Other / unclassified 3 mg/kg Oral
Subject Triferic Other / unclassified 6.6 mg Oral
Background Shohl's solution Unknown Oral

Indications