NCT02442310

Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers

Single Dose Crossover Comparative Bioavailability Study of Deferiprone 600 mg Delayed Release Tablets Versus Deferiprone Oral Solution in Healthy Male and Female Volunteers Following a 1200 mg Dose

• 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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Deferiprone delayed release tablet formulation	Deferiprone 600 mg delayed release tablet formulation
DRUG	Deferiprone oral solution	Deferiprone 100 mg/mL oral solution

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-05-13
• Last updated: 2016-05-13
• Results posted: 2016-05-13

Locations

1 site across 1 country: Canada