NCT02980458

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
Last Updated

December 7, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

November 22, 2016

Last Update Submit

December 6, 2016

Conditions

Bioequivalence

Keywords

HealthyBioequivalenceDeferiprone

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration versus time curve (AUC0-tlast) for deferiprone

    8 hours interval

  • Peak Plasma Concentration (Cmax) for deferiprone

    8 hours interval

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events

    from fist dose until discharge of the subject (approx. 2 weeks)

Study Arms (2)

Deferiprone 500 Lipomed film-coated tablets

EXPERIMENTAL

Oral fasted administration of one film-coated tablet of Deferiprone 500 Lipomed film-coated tablets (Lipomed AG, Switzerland), containing 500 mg deferiprone

Drug: Deferiprone 500Mg Tablet

Ferriprox® film-coated tablets

ACTIVE COMPARATOR

Oral fasted administration of one film-coated tablet of Ferriprox® film-coated tablets (Apotex Europe B.V., Germany), containing 500 mg deferiprone

Drug: Deferiprone 500 MG Oral Tablet [Ferriprox]

Interventions

Deferiprone 500Mg TabletDRUG
Deferiprone 500 Lipomed film-coated tablets
Deferiprone 500 MG Oral Tablet [Ferriprox]DRUG
Ferriprox® film-coated tablets

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sex: male
  • ethnic origin: Caucasian
  • age: 18 years or older
  • body-mass index (BMI): \>=18.5 kg/m² and \<= 30.0 kg/m²
  • good state of health
  • non-smoker or ex-smoker for at least 1 month
  • written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

You may not qualify if:

  • existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
  • existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
  • existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
  • history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
  • known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
  • subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
  • heart rate \< 50 bpm
  • laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
  • laboratory values: CRP \> 5 mg/L, ASAT \> 20 % ULN, ALAT \> 10 % ULN, bilirubin \> 20 % ULN and creatinine \> 0.1 mg/dL
  • positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test (if positive to be verified by test for HBc-IgM) or anti-HCV-test
  • history of recurrent episodes of neutropenia or history of agranulocytosis
  • acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
  • history of or current drug or alcohol dependence
  • regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male per day
  • subjects who are on a diet which could affect the pharmacokinetics of the active ingredient
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SocraTec R&D GmbH Clinical Pharmacology Unit

Erfurt, Thuringia, 99084, Germany

Location

MeSH Terms

Interventions

DeferiproneTablets

Intervention Hierarchy (Ancestors)

PyridonesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • Cornelius Koch, MD

    SocraTec R&D GmbH, Clinical Pharmacology Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2016

First Posted

December 2, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 7, 2016

Record last verified: 2016-11

Locations

DE(1)