<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/NCT02189941</url>
  </required_header>
  <id_info>
    <org_study_id>LA43-0114</org_study_id>
    <nct_id>NCT02189941</nct_id>
  </id_info>
  <brief_title>Pilot Study of the Pharmacokinetic Profile of Deferiprone Sustained-Release Formulation in Healthy Volunteers</brief_title>
  <official_title>Pilot Study of the Pharmacokinetic Profile of a Single Dose of Deferiprone Sustained-Release Formulation in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ApoPharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ApoPharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the pharmacokinetic and safety profile of the&#xD;
      sustained-release formulation of deferiprone under both fasting and fed conditions, and&#xD;
      evaluate the relative bioavailability of this sustained-release formulation when compared to&#xD;
      immediate-release formulation of deferiprone under fasting conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was an open-label, single-dose, randomized, three-way crossover study under fed and&#xD;
      fasting conditions designed to determine the pharmacokinetics, safety, and tolerability of&#xD;
      deferiprone sustained-release tablets in healthy volunteers. Subjects were randomized to&#xD;
      receive the following 3 treatments in different orders, with a washout period of 7 days&#xD;
      between treatments:&#xD;
&#xD;
        -  2000 mg of deferiprone sustained-release tablets under fed conditions&#xD;
&#xD;
        -  2000 mg of deferiprone sustained-release tablets under fasted conditions&#xD;
&#xD;
        -  2000 mg of Ferriprox immediate-release tablets under fasted conditions&#xD;
&#xD;
      In each period, blood samples for pharmacokinetics (PK) assessment were collected prior to&#xD;
      dosing and at specified time points up to 24 hours post-dose. Safety assessments were&#xD;
      conducted throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide</measure>
    <time_frame>24-hour interval</time_frame>
    <description>AUCt (Area Under the Curve to the last measured time) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCinf for Serum Deferiprone and Deferiprone 3-O-glucuronide</measure>
    <time_frame>24-hour interval</time_frame>
    <description>AUCinf (Area Under the Curve to infinity) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide</measure>
    <time_frame>24-hour interval</time_frame>
    <description>Cmax (maximum concentration in the serum) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide</measure>
    <time_frame>24-hour interval</time_frame>
    <description>Tmax (the time to Cmax) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thalf for Serum Deferiprone and Deferiprone 3-O-glucuronide</measure>
    <time_frame>24-hour interval</time_frame>
    <description>Thalf (the apparent terminal elimination half-life of the drug) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability of Deferiprone Sustained Release Tablets</measure>
    <time_frame>From time of dose until 24 hours post dose</time_frame>
    <description>The number of participants who experienced adverse events between the time of dosing up to 24 hours post-dose, including any changes of clinical significance in vital signs, 12-lead ECG, and clinical laboratory tests</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Deferiprone sustained-release (fed)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single 1000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deferiprone sustained-release (fasting)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single 1000 mg dose of deferiprone sustained-release under fasting conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deferiprone immediate-release (fasting)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A single 1000 mg dose of Deferiprone immediate-release under fasting conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Deferiprone sustained-release</intervention_name>
    <description>Deferiprone sustained-release tablets</description>
    <arm_group_label>Deferiprone sustained-release (fasting)</arm_group_label>
    <arm_group_label>Deferiprone sustained-release (fed)</arm_group_label>
    <other_name>Deferiprone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Deferiprone immediate-release</intervention_name>
    <description>Deferiprone immediate-release tablets</description>
    <arm_group_label>Deferiprone immediate-release (fasting)</arm_group_label>
    <other_name>Ferriprox</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Meeting the age, body mass index (BMI) and weight requirements.&#xD;
&#xD;
          -  Signing the Informed Consent Form.&#xD;
&#xD;
          -  Acceptable alcohol and/or drug screen at check-in of each period.&#xD;
&#xD;
          -  Acceptable health, blood pressure, pulse rate and temperature at check-in.&#xD;
&#xD;
          -  Being a non-smoker.&#xD;
&#xD;
          -  Female subjects of childbearing potential should be either sexually inactive&#xD;
             (abstinent) for 60 days prior to the first dose of the study and throughout the study,&#xD;
             and for 30 days after completion of the study, or be using an acceptable method of&#xD;
             birth control.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of presence of significant asthma, chronic bronchitis, seizure, diabetes,&#xD;
             migraine, hypertension, cardiovascular, pulmonary, neurological conditions,&#xD;
             psychiatric conditions, hepatic, renal, hematopoietic or gastrointestinal diseases or&#xD;
             ongoing infectious diseases, or any other significant abnormality as evidenced by a&#xD;
             medical history and physical examination.&#xD;
&#xD;
          -  Blood chemistry, hematology, international normalized ratio, partial thromboplastin&#xD;
             time and urinalysis values outside clinically acceptable limits.&#xD;
&#xD;
          -  A positive screen for Hepatitis B surface antigens, Hepatitis C antibodies or HIV.&#xD;
&#xD;
          -  Significant abnormality found on ECG.&#xD;
&#xD;
          -  Known sensitivity to deferiprone or any components of the Ferriprox tablets.&#xD;
&#xD;
          -  Requiring other medication at the time of the study. Oral, injectable or topical&#xD;
             contraceptives, and contraceptive implants are permitted as they are acceptable&#xD;
             methods of contraception.&#xD;
&#xD;
          -  Acetaminophen use within 2 weeks prior to dosing and for the duration of the study.&#xD;
&#xD;
          -  History of drug or alcohol abuse within the last 6 months.&#xD;
&#xD;
          -  Any known enzyme inducing or inhibiting drug taken within 30 days before the study.&#xD;
&#xD;
          -  History of long QT syndrome, cardiac arrhythmias.&#xD;
&#xD;
          -  Infection within two weeks prior to dosing.&#xD;
&#xD;
          -  Participation in an investigational drug study within 30 days prior to first dosing in&#xD;
             this study.&#xD;
&#xD;
          -  Blood donation of 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL&#xD;
             of whole blood within 56 days prior to drug administration.&#xD;
&#xD;
          -  Positive test for pregnancy at medical screening or prior to dosing in either period.&#xD;
&#xD;
          -  Female subjects who are breast-feeding.&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &lt;= 1.0 x 10E9 cells/L prior to dosing for each period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gurinder Rai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Apotex Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Apotex Inc. BioClinical Development</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M9L 1P7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>December 23, 2015</results_first_submitted>
  <results_first_submitted_qc>April 14, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 20, 2016</results_first_posted>
  <last_update_submitted>April 14, 2016</last_update_submitted>
  <last_update_submitted_qc>April 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Deferiprone</keyword>
  <keyword>Deferiprone sustained-release tablets</keyword>
  <keyword>Pharmacokinetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deferiprone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were dosed at the clinic between May and June of 2014</recruitment_details>
      <pre_assignment_details>Subjects were randomized to receive 3 single-dose treatments in different sequences, with a washout of 7 days between doses. Twenty (20) subjects were screened and 12 were randomized. One subject experienced a medical event prior to the first dosing and was excluded from the study, so only 11 subjects received at least 1 dose of study product.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>DFP-SR Fed, Then DFP-SR Fasting, Then Ferriprox Fasting</title>
          <description>Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:&#xD;
One dose of deferiprone sustained-release (DFP-SR) tablets under fed conditions&#xD;
One dose of deferiprone sustained-release tablets under fasting conditions&#xD;
One dose of Ferriprox immediate-release (IR) tablets under fasting conditions</description>
        </group>
        <group group_id="P2">
          <title>DFP-SR Fasting, Then Ferriprox Fasting, Then DFP-SR Fed</title>
          <description>Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:&#xD;
One dose of deferiprone sustained-release tablets under fasting conditions&#xD;
One dose of Ferriprox immediate-release tablets under fasting conditions&#xD;
One dose of deferiprone sustained-release tablets under fed conditions</description>
        </group>
        <group group_id="P3">
          <title>Ferriprox Fasting, Then DFP-SR Fed, Then DFP-SR Fasting</title>
          <description>Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:&#xD;
One dose of Ferriprox immediate-release tablets under fasting conditions&#xD;
One dose of deferiprone sustained-release tablets under fed conditions&#xD;
One dose of deferiprone sustained-release tablets under fasting conditions</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Healthy Volunteers</title>
          <description>Subjects received one dose of deferiprone sustained-release tablets under fed conditions, one dose of deferiprone sustained-release tablets under fasting conditions, and one dose of deferiprone immediate-release tablets under fasting conditions, 7 days apart</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide</title>
        <description>AUCt (Area Under the Curve to the last measured time) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
        <time_frame>24-hour interval</time_frame>
        <population>All subjects who contributed evaluable pharmacokinetics data</population>
        <group_list>
          <group group_id="O1">
            <title>Deferiprone Sustained-release (Fed)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O2">
            <title>Deferiprone Sustained-release (Fasting)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release under fasting conditions.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O3">
            <title>Deferiprone Immediate-release (Fasting)</title>
            <description>A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.&#xD;
Deferiprone immediate-release: Deferiprone immediate-release tablets</description>
          </group>
        </group_list>
        <measure>
          <title>AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide</title>
          <description>AUCt (Area Under the Curve to the last measured time) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
          <population>All subjects who contributed evaluable pharmacokinetics data</population>
          <units>mcg*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Deferiprone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.5" spread="10.0"/>
                    <measurement group_id="O2" value="52.3" spread="14.8"/>
                    <measurement group_id="O3" value="71.1" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deferiprone 3-O-glucuronide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171.9" spread="33.4"/>
                    <measurement group_id="O2" value="147.2" spread="41.5"/>
                    <measurement group_id="O3" value="192.7" spread="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUCinf for Serum Deferiprone and Deferiprone 3-O-glucuronide</title>
        <description>AUCinf (Area Under the Curve to infinity) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
        <time_frame>24-hour interval</time_frame>
        <population>All subjects who contributed evaluable pharmacokinetics data</population>
        <group_list>
          <group group_id="O1">
            <title>Deferiprone Sustained-release (Fed)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O2">
            <title>Deferiprone Sustained-release (Fasting)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release under fasting conditions.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O3">
            <title>Deferiprone Immediate-release (Fasting)</title>
            <description>A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.&#xD;
Deferiprone immediate-release: Deferiprone immediate-release tablets</description>
          </group>
        </group_list>
        <measure>
          <title>AUCinf for Serum Deferiprone and Deferiprone 3-O-glucuronide</title>
          <description>AUCinf (Area Under the Curve to infinity) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
          <population>All subjects who contributed evaluable pharmacokinetics data</population>
          <units>mcg*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Deferiprone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.2" spread="11.1"/>
                    <measurement group_id="O2" value="57.2" spread="16.1"/>
                    <measurement group_id="O3" value="71.6" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deferiprone 3-O-glucuronide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="181.3" spread="39.9"/>
                    <measurement group_id="O2" value="169.2" spread="62.3"/>
                    <measurement group_id="O3" value="193.4" spread="32.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide</title>
        <description>Cmax (maximum concentration in the serum) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
        <time_frame>24-hour interval</time_frame>
        <population>All subjects who contributed evaluable pharmacokinetics data</population>
        <group_list>
          <group group_id="O1">
            <title>Deferiprone Sustained-release (Fed)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O2">
            <title>Deferiprone Sustained-release (Fasting)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release under fasting conditions.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O3">
            <title>Deferiprone Immediate-release (Fasting)</title>
            <description>A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.&#xD;
Deferiprone immediate-release: Deferiprone immediate-release tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide</title>
          <description>Cmax (maximum concentration in the serum) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
          <population>All subjects who contributed evaluable pharmacokinetics data</population>
          <units>mcg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Deferiprone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="1.8"/>
                    <measurement group_id="O2" value="5.8" spread="1.6"/>
                    <measurement group_id="O3" value="21.9" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deferiprone 3-O-glucuronide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.5" spread="4.2"/>
                    <measurement group_id="O2" value="14.3" spread="2.9"/>
                    <measurement group_id="O3" value="33.2" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide</title>
        <description>Tmax (the time to Cmax) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
        <time_frame>24-hour interval</time_frame>
        <population>All subjects who contributed evaluable pharmacokinetics data</population>
        <group_list>
          <group group_id="O1">
            <title>Deferiprone Sustained-release (Fed)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O2">
            <title>Deferiprone Sustained-release (Fasting)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release under fasting conditions.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O3">
            <title>Deferiprone Immediate-release (Fasting)</title>
            <description>A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.&#xD;
Deferiprone immediate-release: Deferiprone immediate-release tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide</title>
          <description>Tmax (the time to Cmax) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
          <population>All subjects who contributed evaluable pharmacokinetics data</population>
          <units>h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Deferiprone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="0.9"/>
                    <measurement group_id="O2" value="3.3" spread="1.4"/>
                    <measurement group_id="O3" value="1.3" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deferiprone 3-O-glucuronide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="1.5"/>
                    <measurement group_id="O2" value="4.5" spread="1.5"/>
                    <measurement group_id="O3" value="3.0" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Thalf for Serum Deferiprone and Deferiprone 3-O-glucuronide</title>
        <description>Thalf (the apparent terminal elimination half-life of the drug) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
        <time_frame>24-hour interval</time_frame>
        <population>All subjects who contributed evaluable pharmacokinetics data</population>
        <group_list>
          <group group_id="O1">
            <title>Deferiprone Sustained-release (Fed)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O2">
            <title>Deferiprone Sustained-release (Fasting)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release under fasting conditions.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O3">
            <title>Deferiprone Immediate-release (Fasting)</title>
            <description>A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.&#xD;
Deferiprone immediate-release: Deferiprone immediate-release tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Thalf for Serum Deferiprone and Deferiprone 3-O-glucuronide</title>
          <description>Thalf (the apparent terminal elimination half-life of the drug) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.</description>
          <population>All subjects who contributed evaluable pharmacokinetics data</population>
          <units>h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Deferiprone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="1.4"/>
                    <measurement group_id="O2" value="5.0" spread="3.5"/>
                    <measurement group_id="O3" value="1.9" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deferiprone 3-O-glucuronide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="3.4"/>
                    <measurement group_id="O2" value="6.1" spread="4.9"/>
                    <measurement group_id="O3" value="2.4" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety and Tolerability of Deferiprone Sustained Release Tablets</title>
        <description>The number of participants who experienced adverse events between the time of dosing up to 24 hours post-dose, including any changes of clinical significance in vital signs, 12-lead ECG, and clinical laboratory tests</description>
        <time_frame>From time of dose until 24 hours post dose</time_frame>
        <population>All subjects who received at least one dose of study medication and had at least one safety assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Deferiprone Sustained-release (Fed)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O2">
            <title>Deferiprone Sustained-release (Fasting)</title>
            <description>A single 2000 mg dose of deferiprone sustained-release under fasting conditions.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
          </group>
          <group group_id="O3">
            <title>Deferiprone Immediate-release (Fasting)</title>
            <description>A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.&#xD;
Deferiprone immediate-release: Deferiprone immediate-release tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability of Deferiprone Sustained Release Tablets</title>
          <description>The number of participants who experienced adverse events between the time of dosing up to 24 hours post-dose, including any changes of clinical significance in vital signs, 12-lead ECG, and clinical laboratory tests</description>
          <population>All subjects who received at least one dose of study medication and had at least one safety assessment</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <desc>Safety data were collected from the time of dosing up to 24 hours post-dose</desc>
      <group_list>
        <group group_id="E1">
          <title>Deferiprone Sustained-release (Fed)</title>
          <description>A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
        </group>
        <group group_id="E2">
          <title>Deferiprone Sustained-release (Fasting)</title>
          <description>A single 2000 mg dose of deferiprone sustained-release under fasting conditions.&#xD;
Deferiprone sustained-release: Deferiprone sustained-release tablets</description>
        </group>
        <group group_id="E3">
          <title>Deferiprone Immediate-release (Fasting)</title>
          <description>A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.&#xD;
Deferiprone immediate-release: Deferiprone immediate-release tablets</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site bruise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Heart rate decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood pressure decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>White blood cells urine positive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Serum ferritin decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Fernando Tricta, MD</name_or_title>
      <organization>ApoPharma Inc.</organization>
      <phone>416-401-7332</phone>
      <email>ftricta@apopharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02189941
org study id: LA43-0114
nct id: NCT02189941
lead sponsor: 
has dmc: No
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.
This was an open-label, single-dose, randomized, three-way crossover study under fed and
      fasting conditions designed to determine the pharmacokinetics, safety, and tolerability of
      deferiprone sustained-release tablets in healthy volunteers. Subjects were randomized to
      receive the following 3 treatments in different orders, with a washout period of 7 days
      between treatments:

        -  2000 mg of deferiprone sustained-release tablets under fed conditions

        -  2000 mg of deferiprone sustained-release tablets under fasted conditions

        -  2000 mg of Ferriprox immediate-release tablets under fasted conditions

      In each period, blood samples for pharmacokinetics (PK) assessment were collected prior to
      dosing and at specified time points up to 24 hours post-dose. Safety assessments were
      conducted throughout the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide
time frame: 24-hour interval
description: AUCt (Area Under the Curve to the last measured time) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.
measure: AUCinf for Serum Deferiprone and Deferiprone 3-O-glucuronide
time frame: 24-hour interval
description: AUCinf (Area Under the Curve to infinity) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.
measure: Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
time frame: 24-hour interval
description: Cmax (maximum concentration in the serum) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.
measure: Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
time frame: 24-hour interval
description: Tmax (the time to Cmax) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.
measure: Thalf for Serum Deferiprone and Deferiprone 3-O-glucuronide
time frame: 24-hour interval
description: Thalf (the apparent terminal elimination half-life of the drug) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.
measure: Safety and Tolerability of Deferiprone Sustained Release Tablets
time frame: From time of dose until 24 hours post dose
description: The number of participants who experienced adverse events between the time of dosing up to 24 hours post-dose, including any changes of clinical significance in vital signs, 12-lead ECG, and clinical laboratory tests
arm group label: Deferiprone sustained-release (fed)
arm group type: Experimental
description: A single 1000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.
arm group label: Deferiprone sustained-release (fasting)
arm group type: Experimental
description: A single 1000 mg dose of deferiprone sustained-release under fasting conditions.
arm group label: Deferiprone immediate-release (fasting)
arm group type: Active Comparator
description: A single 1000 mg dose of Deferiprone immediate-release under fasting conditions.
intervention type: Drug
intervention name: Deferiprone sustained-release
description: Deferiprone sustained-release tablets
arm group label: Deferiprone sustained-release (fasting)
arm group label: Deferiprone sustained-release (fed)
other name: Deferiprone
intervention type: Drug
intervention name: Deferiprone immediate-release
description: Deferiprone immediate-release tablets
arm group label: Deferiprone immediate-release (fasting)
other name: Ferriprox
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gurinder Rai, MD
role: Principal Investigator
affiliation: Apotex Inc.
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Deferiprone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 