NCT02465489

Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers

Single-dose Pharmacokinetic Study of Deferiprone Extended Release Tablets Versus Ferriprox Immediate Release Tablets Under Fasting and Fed Conditions in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ApoPharma · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Deferiprone extended release	Deferiprone 1000 mg extended release tablet formulation
DRUG	Deferiprone immediate release	Ferriprox (deferiprone) 500 mg immediate release tablet formulation

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-06-08
• Last updated: 2016-02-26
• Results posted: 2016-01-26

Locations

1 site across 1 country: Canada