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

NCT02189941 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-05-20

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Deferiprone sustained-release

Deferiprone sustained-release tablets

DRUG

Deferiprone immediate-release

Deferiprone immediate-release tablets

Sponsors & Collaborators

  • ApoPharma

    lead INDUSTRY

Principal Investigators

  • Gurinder Rai, MD · Apotex Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02189941 on ClinicalTrials.gov