Conditions: Healthy
Keywords: deferiprone deferiprone extended 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 extended release tablets) under fed and fasting conditions.

Detailed description:
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.

Arms:
arm 1: A single 1000 mg dose of deferiprone extended release tablet formulation administered under fasting conditions arm 2: A single 1000 mg dose of deferiprone extended release tablet formulation administered under fed conditions arm 3: A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered under fed conditions arm 4: A single 1000 mg dose of deferiprone immediate release tablet formulation administered under fasting conditions arm 5: A single 1000 mg dose of deferiprone immediate release tablet formulation administered under fed conditions

Interventions: intervention 1: Deferiprone extended release intervention 2: Deferiprone immediate release
Intervention descriptions: intervention 1: Deferiprone 1000 mg extended release tablet formulation intervention 2: Ferriprox (deferiprone) 500 mg immediate release tablet formulation

Protocol document: