<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/NCT01724788</url>
  </required_header>
  <id_info>
    <org_study_id>FUROSL06121</org_study_id>
    <secondary_id>U1111-1127-0839</secondary_id>
    <nct_id>NCT01724788</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis</brief_title>
  <official_title>Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation (PRLasix® Special, Tablets 500 mg) in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
        -  To determine the absolute bioavailability of furosemide 500 mg (Lasix® Special) oral&#xD;
           formulation in patients with chronic renal failure undergoing peritoneal dialysis.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To determine the pharmacokinetic profiles of furosemide 500 mg (Lasix® Special) oral&#xD;
           formulation and 250 mg IV formulation&#xD;
&#xD;
        -  To compare the pharmacodynamic characteristics of furosemide 500 mg (Lasix® Special)&#xD;
           oral formulation and 250 mg IV formulation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Screening: 7 to 10 days&#xD;
&#xD;
        -  Treatment period: 14 days (Period 1: 7 days; Period 2: 7 days)&#xD;
&#xD;
        -  End of study: 7 days after the last dosing,&#xD;
&#xD;
        -  Total duration from screening per subject: 22 to 25 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute bioavailability (F) of a single 500-mg oral tablet</measure>
    <time_frame>Day 1, 4, 8, 11</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Cmax (maximum (peak) plasma drug concentration) after single dose administration</measure>
    <time_frame>Day 1, 4, 8, 11</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Tmax (time to reach peak or maximum concentration) following drug administration</measure>
    <time_frame>Day 1, 4, 8, 11</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the pharmacokinetic parameters of furosemide (po and iv) measured by AUCT 0-72 (area under curve from the time zero to 72h)</measure>
    <time_frame>Day 1, 4, 8, 11</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine pharmacodynamic characteristics of furosemide (po and iv) including the excretion against time of urinary volume, urinary excretion, urea and creatinine</measure>
    <time_frame>0, 6, 12, 24 h</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Renal Failure</condition>
  <arm_group>
    <arm_group_label>Furosemide PO - IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral furosemide allocated at the beginning of Period 1, then cross-over to IV furosemide (a minimum 7-day diuretic free washout period required between the two periods)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Furosemide IV - PO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV furosemide allocated at the beginning of Period 1, then cross-over to oral furosemide (a minimum 7-day diuretic free washout period required between the two periods)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FUROSEMIDE</intervention_name>
    <description>Pharmaceutical form: Solution Route of administration: Intravenous</description>
    <arm_group_label>Furosemide IV - PO</arm_group_label>
    <arm_group_label>Furosemide PO - IV</arm_group_label>
    <other_name>Furosemide Special Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FUROSEMIDE (HOE058)</intervention_name>
    <description>Pharmaceutical form: Tablet Route of administration: Oral</description>
    <arm_group_label>Furosemide IV - PO</arm_group_label>
    <arm_group_label>Furosemide PO - IV</arm_group_label>
    <other_name>Lasix® Special</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Male or female, 18 years old or older, with chronic renal failure undergoing&#xD;
             peritoneal dialysis for at least 3 months.&#xD;
&#xD;
          -  Women of childbearing age should have a negative pregnancy test before administration&#xD;
             of the study drug&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Contra-indications to furosemide, including:&#xD;
&#xD;
               -  Hypersensitivity to furosemide or to sulphonamide-derived drugs or to any&#xD;
                  ingredient in the formulation or component of the container.&#xD;
&#xD;
               -  Glomerular filtration rate below 5 mL/min&#xD;
&#xD;
               -  Glomerular filtration rate above 20 mL/min&#xD;
&#xD;
               -  Severe liver disease&#xD;
&#xD;
               -  Patients with renal failure accompanied by hepatic coma and precoma&#xD;
&#xD;
               -  Renal failure due to poisoning with nephrotoxic or hepatotoxic substances&#xD;
&#xD;
               -  Severe hyponatremia, hypokalemia, hypovolemia, dehydration or hypotension&#xD;
&#xD;
               -  Nursing women&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Treatment with any diuretic, which cannot be discontinued with the required washout&#xD;
             period before the first drug administration&#xD;
&#xD;
          -  Existence of any surgical or medical condition, which, in the judgment of the clinical&#xD;
             investigator, might interfere with absorption, distribution, metabolism or excretion&#xD;
             of drugs.&#xD;
&#xD;
          -  Psychiatric or cognitive disturbance or illness, or recreational drug/alcohol use&#xD;
             that, in the opinion of the principal investigator, would affect patient safety and/or&#xD;
             compliance.&#xD;
&#xD;
          -  Treatment with the following inhibitors of secretion at the renal level:&#xD;
             clarithromycin, erythromycin, itraconazole, cyclosporin, ketoconazole, quinidine, and&#xD;
             verapamil, which cannot be discontinued during the course of the study.&#xD;
&#xD;
        Interfering substance:Subjects must abstain from alcohol and beverages containing&#xD;
        stimulating xanthine derivates (e.g. coffee and tea) during the entire study period.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 124002</name>
      <address>
        <city>Montreal</city>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>February 11, 2013</last_update_submitted>
  <last_update_submitted_qc>February 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Furosemide</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/NCT01724788
org study id: FUROSL06121
secondary id: U1111-1127-0839
nct id: NCT01724788
lead sponsor: 
has dmc: No
Primary Objective:

        -  To determine the absolute bioavailability of furosemide 500 mg (Lasix® Special) oral
           formulation in patients with chronic renal failure undergoing peritoneal dialysis.

      Secondary Objectives:

        -  To determine the pharmacokinetic profiles of furosemide 500 mg (Lasix® Special) oral
           formulation and 250 mg IV formulation

        -  To compare the pharmacodynamic characteristics of furosemide 500 mg (Lasix® Special)
           oral formulation and 250 mg IV formulation
-  Screening: 7 to 10 days

        -  Treatment period: 14 days (Period 1: 7 days; Period 2: 7 days)

        -  End of study: 7 days after the last dosing,

        -  Total duration from screening per subject: 22 to 25 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Absolute bioavailability (F) of a single 500-mg oral tablet
time frame: Day 1, 4, 8, 11
measure: To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Cmax (maximum (peak) plasma drug concentration) after single dose administration
time frame: Day 1, 4, 8, 11
measure: To determine the pharmacokinetic parameters of furosemide (po and iv) measured by Tmax (time to reach peak or maximum concentration) following drug administration
time frame: Day 1, 4, 8, 11
measure: To determine the pharmacokinetic parameters of furosemide (po and iv) measured by AUCT 0-72 (area under curve from the time zero to 72h)
time frame: Day 1, 4, 8, 11
measure: To determine pharmacodynamic characteristics of furosemide (po and iv) including the excretion against time of urinary volume, urinary excretion, urea and creatinine
time frame: 0, 6, 12, 24 h
arm group label: Furosemide PO - IV
arm group type: Experimental
description: Oral furosemide allocated at the beginning of Period 1, then cross-over to IV furosemide (a minimum 7-day diuretic free washout period required between the two periods)
arm group label: Furosemide IV - PO
arm group type: Experimental
description: IV furosemide allocated at the beginning of Period 1, then cross-over to oral furosemide (a minimum 7-day diuretic free washout period required between the two periods)
intervention type: Drug
intervention name: FUROSEMIDE
description: Pharmaceutical form: Solution Route of administration: Intravenous
arm group label: Furosemide IV - PO
arm group label: Furosemide PO - IV
other name: Furosemide Special Injection
intervention type: Drug
intervention name: FUROSEMIDE (HOE058)
description: Pharmaceutical form: Tablet Route of administration: Oral
arm group label: Furosemide IV - PO
arm group label: Furosemide PO - IV
other name: Lasix® Special
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Furosemide