NCT02065401

Pharmacokinetics of Granule and Tablet Formulations of Deferitazole (Disodium Salt) and a Capsule Formulation of Deferitazole (Magnesium Hydroxide Salt)

A Phase 1, Open-label, Randomized, 3-Period, Relative Bioavailability Study Comparing the Pharmacokinetics of Granule and Tablet Formulations of Deferitazole (Disodium Salt) and a Capsule Formulation of Deferitazole (Magnesium Hydroxide Salt), Each Administered as a Single Oral Dose

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the pharmacokinetic profiles of deferitazole after administration of granule and tablet formulations of a deferitazole disodium salt to a capsule formulation of deferitazole magnesium hydroxide salt (reference formulation) in healthy adult subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Deferitazole (disodium salt, granule)	Single oral dose of 1500 mg administered on Day 1
DRUG	Deferitazole (disodium salt, tablet)	Single oral dose of 1500 mg administered on Day 1
DRUG	Deferitazole (magnesium hydroxide salt)	Single oral dose of 2400 mg administered on Day 1

Timeline

• Start date: 2014-02-28
• Primary completion: 2014-03-19
• Completion: 2014-03-19
• First posted: 2014-02-19
• Last updated: 2021-06-02

Locations

1 site across 1 country: United States