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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Single oral dose of 1500 mg administered on Day 1
Single oral dose of 1500 mg administered on Day 1
Single oral dose of 2400 mg administered on Day 1
Clinical Pharmacology of Miami
Miami, Florida, United States
Area Under the Plasma Concentration-time Curve (AUC) of Deferitazole
AUC of disodium salt granule, disodium salt tablet, and magnesium hydroxide salt
Time frame: Up to 120 hours post-dose
Maximum Plasma Concentration (Cmax) of Deferitazole
Cmax of disodium salt granule, disodium salt tablet, and magnesium hydroxide salt
Time frame: Up to 120 hours post-dose
Taste of Deferitazole
Time frame: Immediately after dose and 5 minutes post-dose
Bioequivalence of Deferitazole Disodium Salt Granule Formulation With Tablet Formulation
Compare the pharmacokinetic profile of granule formulation with pharmacokinetic profile of tablet formulation
Time frame: Up to 120 hours post-dose
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