The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone extended release tablets) under fed and fasting conditions.
This is a single-center, open-label, randomized, 5-period, 5-sequence study of the pharmacokinetics of a new formulation of deferiprone, extended release tablets, in twenty healthy volunteers. In each study period, blood samples for pharmacokinetics assessment will be collected pre-dose and over 24 hours post-dose. Safety will be assessed throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
20
Deferiprone 1000 mg extended release tablet formulation
Ferriprox (deferiprone) 500 mg immediate release tablet formulation
Algorithme Pharma Inc.
Mount Royal, Quebec, Canada
Cmax for Serum Deferiprone
Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Time frame: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.
Tmax for Serum Deferiprone
Time of maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Time frame: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.
AUC0-∞for Serum Deferiprone
Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose.
Time frame: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.
Number of Subjects With Adverse Events (AEs)
Number of subjects with AEs. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.
Time frame: Throughout the trial, from the time of the first dose until the last study visit (Day 36 or early termination)
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