Conditions: Healthy
Keywords: Deferiprone Deferiprone sustained-release tablets Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 11
Healthy volunteers: yes

Brief summary:
The purpose of this study was to evaluate the pharmacokinetic and safety profile of the sustained-release formulation of deferiprone under both fasting and fed conditions, and evaluate the relative bioavailability of this sustained-release formulation when compared to immediate-release formulation of deferiprone under fasting conditions.

Detailed description:
This was an open-label, single-dose, randomized, three-way crossover study under fed and fasting conditions designed to determine the pharmacokinetics, safety, and tolerability of deferiprone sustained-release tablets in healthy volunteers. Subjects were randomized to receive the following 3 treatments in different orders, with a washout period of 7 days between treatments:

* 2000 mg of deferiprone sustained-release tablets under fed conditions
* 2000 mg of deferiprone sustained-release tablets under fasted conditions
* 2000 mg of Ferriprox immediate-release tablets under fasted conditions

In each period, blood samples for pharmacokinetics (PK) assessment were collected prior to dosing and at specified time points up to 24 hours post-dose. Safety assessments were conducted throughout the study.

Arms:
arm 1: A single 1000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast. arm 2: A single 1000 mg dose of deferiprone sustained-release under fasting conditions. arm 3: A single 1000 mg dose of Deferiprone immediate-release under fasting conditions.

Interventions: intervention 1: Deferiprone sustained-release intervention 2: Deferiprone immediate-release
Intervention descriptions: intervention 1: Deferiprone sustained-release tablets intervention 2: Deferiprone immediate-release tablets

Protocol document: