Conditions: Healthy
Keywords: deferiprone deferiprone delayed release formulation pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast arm 2: A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast arm 3: A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast arm 4: A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast

Interventions: intervention 1: Deferiprone delayed release tablet formulation intervention 2: Deferiprone oral solution
Intervention descriptions: intervention 1: Deferiprone 600 mg delayed release tablet formulation intervention 2: Deferiprone 100 mg/mL oral solution

Protocol document: