Overview

A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA

Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
This is a Phase II, open-label, non-randomized, multi-center, single arm study to characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or 15 mg/kg dose of Ferric Carboxymaltose.
Phase:
Phase 2
Details
Lead Sponsor:
American Regent, Inc.
Luitpold Pharmaceuticals
Treatments:
Ferric Compounds