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Characterisation of Relative Bioavailability With Bioequivalence Assessment of Deferiprone Tablets After Oral Single Dose Administration

NCT02980458 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-12-07

No results posted yet for this study

Summary

The present study will be conducted in order to compare the bioavailability of the generic Test product (Deferiprone 500 Lipomed tablets, Lipomed AG, Switzerland) with a marketed Reference product (Ferriprox® film-coated tablets, Apotex Europe B.V., Germany) both containing 500 mg deferiprone. For this issue the pharmacokinetics will be characterised after single dose administration of each one tablet.

Conditions

  • Bioequivalence

Interventions

DRUG

Deferiprone 500Mg Tablet

DRUG

Deferiprone 500 MG Oral Tablet [Ferriprox]

Sponsors & Collaborators

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • SocraTec R&D GmbH

    lead OTHER

Principal Investigators

  • Cornelius Koch, MD · SocraTec R&D GmbH, Clinical Pharmacology Unit

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Germany

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 NCT02980458 on ClinicalTrials.gov