Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers

NCT04626414 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-08-24

Study results available
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Summary

The purpose of the study is to compare the Pharmacokinetics (PK) of the new ferric maltol suspension, in adults, with the existing ferric maltol capsule.

Conditions

  • Anemia, Iron Deficiency

Interventions

DRUG

Ferric maltol capsule

single dose of 30 mg capsule

DRUG

Ferric maltol suspension

single dose of 30mg (5ml) oral suspension

Sponsors & Collaborators

  • Shield Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jackie Mitchell, DPhil · Shield Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2020-11-13
Completion
2020-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04626414 on ClinicalTrials.gov