NCT02189941

Pilot Study of the Pharmacokinetic Profile of Deferiprone Sustained-Release Formulation in Healthy Volunteers

Pilot Study of the Pharmacokinetic Profile of a Single Dose of Deferiprone Sustained-Release Formulation in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: ApoPharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Deferiprone sustained-release	Deferiprone sustained-release tablets
DRUG	Deferiprone immediate-release	Deferiprone immediate-release tablets

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-07-15
• Last updated: 2016-05-20
• Results posted: 2016-05-20

Locations

1 site across 1 country: Canada