<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02980458</url>
  </required_header>
  <id_info>
    <org_study_id>1221def09ct</org_study_id>
    <nct_id>NCT02980458</nct_id>
  </id_info>
  <brief_title>Characterisation of Relative Bioavailability With Bioequivalence Assessment of Deferiprone Tablets After Oral Single Dose Administration</brief_title>
  <official_title>Characterisation of Relative Bioavailability of a Generic Deferiprone Formulation in Comparison With a Marketed Reference Product in a Single Dose, 2-period-crossover Design Under Fasting Conditions; Controlled, Open, Randomised, no Blinded Study With Bioequivalence Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SocraTec R&amp;D GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SocraMetrics GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>SocraTec R&amp;D GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study will be conducted in order to compare the bioavailability of the generic&#xD;
      Test product (Deferiprone 500 Lipomed tablets, Lipomed AG, Switzerland) with a marketed&#xD;
      Reference product (Ferriprox® film-coated tablets, Apotex Europe B.V., Germany) both&#xD;
      containing 500 mg deferiprone. For this issue the pharmacokinetics will be characterised&#xD;
      after single dose administration of each one tablet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be performed in an open-label, randomised (order of treatments), single dose,&#xD;
      2 period cross-over design with a wash out phase of at least three treatment free days&#xD;
      between both administrations. Sample collection will be performed over eight hours after&#xD;
      fasted administration. This time is considered adequate for the determination of plasma&#xD;
      concentration vs. time profiles long enough for reliable estimation of the extent of&#xD;
      absorption, i.e. the AUC derived from measurements is expected to cover at least 80% of the&#xD;
      AUC extrapolated to infinity for deferiprone&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC0-tlast) for deferiprone</measure>
    <time_frame>8 hours interval</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax) for deferiprone</measure>
    <time_frame>8 hours interval</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events</measure>
    <time_frame>from fist dose until discharge of the subject (approx. 2 weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Bioequivalence</condition>
  <arm_group>
    <arm_group_label>Deferiprone 500 Lipomed film-coated tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral fasted administration of one film-coated tablet of Deferiprone 500 Lipomed film-coated tablets (Lipomed AG, Switzerland), containing 500 mg deferiprone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ferriprox® film-coated tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral fasted administration of one film-coated tablet of Ferriprox® film-coated tablets (Apotex Europe B.V., Germany), containing 500 mg deferiprone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Deferiprone 500Mg Tablet</intervention_name>
    <arm_group_label>Deferiprone 500 Lipomed film-coated tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Deferiprone 500 MG Oral Tablet [Ferriprox]</intervention_name>
    <arm_group_label>Ferriprox® film-coated tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. sex: male&#xD;
&#xD;
          2. ethnic origin: Caucasian&#xD;
&#xD;
          3. age: 18 years or older&#xD;
&#xD;
          4. body-mass index (BMI): &gt;=18.5 kg/m² and &lt;= 30.0 kg/m²&#xD;
&#xD;
          5. good state of health&#xD;
&#xD;
          6. non-smoker or ex-smoker for at least 1 month&#xD;
&#xD;
          7. written informed consent, after having been informed about benefits and potential&#xD;
             risks of the clinical trial, as well as details of the insurance taken out to cover&#xD;
             the subjects participating in the clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. existing cardiac and/or haematological diseases or pathological findings, which might&#xD;
             interfere with the safety or tolerability of the active ingredient&#xD;
&#xD;
          2. existing hepatic and/or renal diseases or pathological findings, which might interfere&#xD;
             with the safety or tolerability, and/or pharmacokinetics of the active ingredient&#xD;
&#xD;
          3. existing gastrointestinal diseases or pathological findings, which might interfere&#xD;
             with the safety, tolerability, absorption and/or pharmacokinetics of the active&#xD;
             ingredient&#xD;
&#xD;
          4. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS&#xD;
             and/or psychiatric disorders&#xD;
&#xD;
          5. known allergic reactions to the active ingredients used or to constituents of the&#xD;
             pharmaceutical preparations&#xD;
&#xD;
          6. subjects with severe allergies or multiple drug allergies unless it is judged as not&#xD;
             relevant for the clinical trial by the investigator&#xD;
&#xD;
          7. heart rate &lt; 50 bpm&#xD;
&#xD;
          8. laboratory values out of normal range unless the deviation from normal is judged as&#xD;
             not relevant for the clinical trial by the investigator&#xD;
&#xD;
          9. laboratory values: CRP &gt; 5 mg/L, ASAT &gt; 20 % ULN, ALAT &gt; 10 % ULN, bilirubin &gt; 20 %&#xD;
             ULN and creatinine &gt; 0.1 mg/dL&#xD;
&#xD;
         10. positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test (if&#xD;
             positive to be verified by test for HBc-IgM) or anti-HCV-test&#xD;
&#xD;
         11. history of recurrent episodes of neutropenia or history of agranulocytosis&#xD;
&#xD;
         12. acute or chronic diseases which may interfere with the pharmacokinetics of the IMP&#xD;
&#xD;
         13. history of or current drug or alcohol dependence&#xD;
&#xD;
         14. regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male per day&#xD;
&#xD;
         15. subjects who are on a diet which could affect the pharmacokinetics of the active&#xD;
             ingredient&#xD;
&#xD;
         16. regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day&#xD;
&#xD;
         17. blood donation or other blood loss of more than 400 ml within the last 2 months prior&#xD;
             to individual enrolment of the subject&#xD;
&#xD;
         18. administration of any investigational medicinal product during the last 2 months prior&#xD;
             to individual enrolment of the subject&#xD;
&#xD;
         19. regular treatment with any systemically available medication&#xD;
&#xD;
         20. treatment with medicinal products which might cause neutropenia or agranulocytosis&#xD;
&#xD;
         21. subjects, who report a frequent occurrence of migraine attacks&#xD;
&#xD;
         22. subjects suspected or known not to follow instructions&#xD;
&#xD;
         23. subjects who are unable to understand the written and verbal instructions, in&#xD;
             particular regarding the risks and inconveniences they will be exposed to during their&#xD;
             participation in the clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cornelius Koch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SocraTec R&amp;D GmbH, Clinical Pharmacology Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SocraTec R&amp;D GmbH Clinical Pharmacology Unit</name>
      <address>
        <city>Erfurt</city>
        <state>Thüringen</state>
        <zip>99084</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>Bioequivalence</keyword>
  <keyword>Deferiprone</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deferiprone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02980458
org study id: 1221def09ct
nct id: NCT02980458
lead sponsor: 
collaborator: 
has dmc: No
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.
The study will be performed in an open-label, randomised (order of treatments), single dose,
      2 period cross-over design with a wash out phase of at least three treatment free days
      between both administrations. Sample collection will be performed over eight hours after
      fasted administration. This time is considered adequate for the determination of plasma
      concentration vs. time profiles long enough for reliable estimation of the extent of
      absorption, i.e. the AUC derived from measurements is expected to cover at least 80% of the
      AUC extrapolated to infinity for deferiprone
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Area under the plasma concentration versus time curve (AUC0-tlast) for deferiprone
time frame: 8 hours interval
measure: Peak Plasma Concentration (Cmax) for deferiprone
time frame: 8 hours interval
measure: Number of participants with treatment-related adverse events
time frame: from fist dose until discharge of the subject (approx. 2 weeks)
arm group label: Deferiprone 500 Lipomed film-coated tablets
arm group type: Experimental
description: Oral fasted administration of one film-coated tablet of Deferiprone 500 Lipomed film-coated tablets (Lipomed AG, Switzerland), containing 500 mg deferiprone
arm group label: Ferriprox® film-coated tablets
arm group type: Active Comparator
description: Oral fasted administration of one film-coated tablet of Ferriprox® film-coated tablets (Apotex Europe B.V., Germany), containing 500 mg deferiprone
intervention type: Drug
intervention name: Deferiprone 500Mg Tablet
arm group label: Deferiprone 500 Lipomed film-coated tablets
intervention type: Drug
intervention name: Deferiprone 500 MG Oral Tablet [Ferriprox]
arm group label: Ferriprox® film-coated tablets
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cornelius Koch, MD
role: Principal Investigator
affiliation: SocraTec R&D GmbH, Clinical Pharmacology Unit
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Deferiprone