The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.
This is a single-center, open-label, randomized, 4-period crossover study of the pharmacokinetics of a new formulation of deferiprone, delayed 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 600 mg delayed release tablet formulation
Deferiprone 100 mg/mL oral solution
Algorithme Pharma Inc.
Mount Royal, Quebec, Canada
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Time frame: 24-hour interval
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time to maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Time frame: 24-hour interval
AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide
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: 24-hour interval
Number of Subjects With Adverse Events (AEs)
Number of subjects with AEs, by frequency, severity, time to onset, duration, and relatedness to study product. 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 30 or early termination)
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