<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/NCT03007888</url>
  </required_header>
  <id_info>
    <org_study_id>IPX203-B16-01</org_study_id>
    <nct_id>NCT03007888</nct_id>
  </id_info>
  <brief_title>A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease</brief_title>
  <official_title>A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Impax Laboratories, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Impax Laboratories, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate&#xD;
      release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.&#xD;
&#xD;
      To compare the efficacy of IPX203 with IR CD-LD following multiple doses.&#xD;
&#xD;
      To evaluate the safety of IPX203.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      IPX203 is an investigational product containing CD-LD.&#xD;
&#xD;
      IPX203-B16-01 Study Design:&#xD;
&#xD;
      A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose&#xD;
      crossover study.&#xD;
&#xD;
      Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized.&#xD;
&#xD;
      The study duration will be approximately 8 weeks, including the screening period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2016</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</primary_completion_date>
  <phase>Phase 2</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Levodopa Cmax Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levodopa Tmax Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levodopa t1/2 Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levodopa AUCt Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levodopa AUCinf Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbidopa Cmax Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbidopa Tmax Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbidopa t1/2 Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbidopa AUCt Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbidopa AUCinf Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levodopa Cmax Following First Dose on Day 15</measure>
    <time_frame>Day 15</time_frame>
    <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levodopa Tmax Following First Dose on Day 15</measure>
    <time_frame>Day 15</time_frame>
    <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levodopa AUCtau Following First Dose on Day 15</measure>
    <time_frame>Day 15</time_frame>
    <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbidopa Cmax Following First Dose on Day 15</measure>
    <time_frame>Day 15</time_frame>
    <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbidopa Tmax Following First Dose on Day 15</measure>
    <time_frame>Day 15</time_frame>
    <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbidopa AUCtau Following First Dose on Day 15</measure>
    <time_frame>Day 15</time_frame>
    <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Advanced Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>IPX203 then Sinemet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablet for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sinemet then IPX203</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants first received Sinemet Capsules for 15 days After a Washout Period of 7 days; participants then received IPX203 ER CD-LD Capsules for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sinemet</intervention_name>
    <description>Immediate Release Tablet containing carbidopa-levodopa flexible dosing</description>
    <arm_group_label>IPX203 then Sinemet</arm_group_label>
    <arm_group_label>Sinemet then IPX203</arm_group_label>
    <other_name>IR CD-LD Tablets</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IPX203</intervention_name>
    <description>Extended Release capsules containing carbidopa-levodopa flexible dosing</description>
    <arm_group_label>IPX203 then Sinemet</arm_group_label>
    <arm_group_label>Sinemet then IPX203</arm_group_label>
    <other_name>IPX203 ER CD-LD Capsules</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility will be determined at screening and Visit 1 of the study.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with idiopathic PD at age ≥ 40 years who are being chronically treated with&#xD;
             stable regimens of CD-LD but experiencing motor complications.&#xD;
&#xD;
          -  Hoehn and Yahr Stages 2, 3, or 4&#xD;
&#xD;
          -  Montreal Cognitive Assessment (MoCA) score ≥ 24 at Screening Visit in &quot;on&quot; state.&#xD;
&#xD;
          -  For the 4 weeks prior to the Screening, the subject experiences daily &quot;wearing-off&quot;&#xD;
             episodes with periods of bradykinesia and rigidity and experiences an &quot;off&quot; state upon&#xD;
             awakening on most mornings by history.&#xD;
&#xD;
          -  Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD&#xD;
             for at least 4 weeks prior to Visit 1&#xD;
&#xD;
          -  Typically experiences an &quot;on&quot; response with the first dose of IR CD-LD of the day (by&#xD;
             subject history).&#xD;
&#xD;
          -  By history, efficacy of the first morning dose of IR CD-LD lasts less than 4 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of medical conditions or of a prior surgical procedure that would interfere&#xD;
             with LD absorption, such as gastrectomy or proximal small-bowel resection.&#xD;
&#xD;
          -  Liver enzyme values ≥ 2.5 x the upper limit of normal; or history of severe hepatic&#xD;
             impairment.&#xD;
&#xD;
          -  History of drug or alcohol abuse within the 12 months prior to Screening.&#xD;
&#xD;
          -  Received within 4 weeks of Visit 1 or planning to take during participation in the&#xD;
             clinical study: any doses of a controlled-release (CR) LD apart from a single daily&#xD;
             bedtime dose or any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg,&#xD;
             Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or&#xD;
             medications containing these inhibitors (Stalevo). Received within 4 weeks of Visit 1&#xD;
             or planning to take during participation in the clinical study: nonselective monoamine&#xD;
             oxidase (MAO) inhibitors, apomorphine, or dopaminergic blocking agents including&#xD;
             antiemetics.&#xD;
&#xD;
          -  History of psychosis within the past 10 years.&#xD;
&#xD;
          -  Treatment with any dopamine antagonist antipsychotics for the purposes of psychosis or&#xD;
             bipolar disorder within the last 2 years.&#xD;
&#xD;
          -  Based on clinical assessment, subject does not adequately comprehend the terminology&#xD;
             needed to complete the PD Diary.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Impax Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Impax Laboratories, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigator 110</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 114</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator 106</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator 112</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator 113</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33980</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 108</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator 101</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 103</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator 109</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 115</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigator 104</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>May 6, 2021</results_first_submitted>
  <results_first_submitted_qc>May 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 6, 2022</results_first_posted>
  <disposition_first_submitted>August 15, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>August 15, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 17, 2018</disposition_first_posted>
  <last_update_submitted>May 11, 2022</last_update_submitted>
  <last_update_submitted_qc>May 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IPX203 (carbidopa-levodopa) Extended-Release capsules</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carbidopa, levodopa drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 5, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03007888/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03007888/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 39 subjects were screened at 10 study sites between November 8, 2016 and August 1, 2017</recruitment_details>
      <pre_assignment_details>28 of 39 subjects were enrolled and randomized</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>IPX203 First Then Sinemet</title>
          <description>Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablets for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.</description>
        </group>
        <group group_id="P2">
          <title>Sinemet First Then IPX203</title>
          <description>Participants first received Sinemet for 15 days After a Washout Period of 7 days; participants then received IPX203 for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention (14 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout (7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Interventions (14 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects who were enrolled and randomized to 1 of 2 treatment sequences</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>The recommended first morning dose of IPX203 on Day 1 was based on the subject's prestudy IR CD-LD morning dose&#xD;
The initial IR CD-LD dosing regimen was the same as the subject's stable prestudy regimen (unless s/he was taking a single daily bedtime dose of CR CD-LD, either alone or in combination with IR CD-LD, in which case, the CR CD-LD dose was discontinued and substituted with a 1:1 milligram-equivalent IR CD-LD dose).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
          </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="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.43" spread="10.057"/>
                  </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>
              <title>Gender</title>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </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="0"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </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>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age at Parkinson's disease onset</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.9" spread="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Parkinson's disease</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.5" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hoehn and Yahr Score</title>
          <description>0:Asymptomatic&#xD;
Unilateral involvement only&#xD;
Bilateral involvement without impairment of balance&#xD;
Mild to moderate involvement; some postural instability but physically independent; needs assistance to recover from pull test&#xD;
Severe disability; still able to walk or stand unassisted&#xD;
Wheelchair bound or bedridden unless aided</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Montreal Cognitive Assessment Score (On State)</title>
          <description>The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. it assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 0 to 30 points; a score of 26 or above is considered normal.&#xD;
Montreal Cognitive Assessment (MoCA) score ≥ 24 is required at Screening Visit in &quot;on&quot; state.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>MoCA score&lt;24</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MoCA score 24 to &lt;26</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MoCA score 26 to &lt;28</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MoCA score 28 to &lt;30</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>30</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale Part III while On</title>
          <description>MDS-UPDRS Part III was administered pre-dose (baseline). It comprises 18 items (speech,facial expression,rigidity,finger tapping,hand movements,pronation-supination hand movements,toe tapping,leg agility,arising from chair,gait,freezing of gait,postural stability,posture,global spontaneity movement, postural tremor of hands,kinetic tremor of hands,rest tremor amplitude,constancy of rest tremor scored on a 5-point normal-to-severe scale including dyskinesia impact questions ranging from 0 to 90 points. The higher the score the more abnormality.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.1" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale Part III while Off</title>
          <description>MDS-UPDRS Part III was administered pre-dose (baseline). It comprises 18 items (speech,facial expression,rigidity,finger tapping,hand movements,pronation-supination hand movements,toe tapping,leg agility,arising from chair,gait,freezing of gait,postural stability,posture,global spontaneity movement, postural tremor of hands,kinetic tremor of hands,rest tremor amplitude,constancy of rest tremor scored on a 5-point normal-to-severe scale including dyskinesia impact questions ranging from 0 to 90 points. The higher the score the more abnormality.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.5" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total &quot;off&quot; time from subject diary</title>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.2" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Good &quot;on&quot; time from subject diary</title>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.9" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Levodopa Cmax Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Levodopa Cmax Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>ng/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="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2857.56" spread="1204.506"/>
                    <measurement group_id="O2" value="2173.30" spread="1240.774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Levodopa Tmax Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Levodopa Tmax Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.07" spread="0.997"/>
                    <measurement group_id="O2" value="0.94" spread="0.560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Levodopa t1/2 Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Levodopa t1/2 Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.658" spread="0.4838"/>
                    <measurement group_id="O2" value="1.420" spread="0.3194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Levodopa AUCt Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Levodopa AUCt Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>ng.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="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12107.60" spread="5793.881"/>
                    <measurement group_id="O2" value="3747.61" spread="1819.141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Levodopa AUCinf Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Levodopa AUCinf Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>ng.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="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13968.57" spread="7606.901"/>
                    <measurement group_id="O2" value="4308.37" spread="2123.057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.965" spread="21.7583"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Carbidopa Cmax Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Carbidopa Cmax Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>ng/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="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500.35" spread="316.299"/>
                    <measurement group_id="O2" value="151.50" spread="103.225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Carbidopa Tmax Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Carbidopa Tmax Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.61" spread="0.655"/>
                    <measurement group_id="O2" value="2.07" spread="0.675"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Carbidopa t1/2 Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Carbidopa t1/2 Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.015" spread="0.5159"/>
                    <measurement group_id="O2" value="1.969" spread="0.7187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Carbidopa AUCt Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Carbidopa AUCt Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>ng.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="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1940.51" spread="1095.449"/>
                    <measurement group_id="O2" value="436.63" spread="286.286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Carbidopa AUCinf Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Carbidopa AUCinf Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>ng.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="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2239.61" spread="1232.234"/>
                    <measurement group_id="O2" value="610.44" spread="407.305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1</title>
        <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
        <time_frame>Day 1</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participants who received IPX203 ER Capsules on Day 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1</title>
          <description>Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose</description>
          <population>Randomized subjects who completed both periods</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.442" spread="43.4176"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Levodopa Cmax Following First Dose on Day 15</title>
        <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
        <time_frame>Day 15</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participant who receive IPX203 ER CD-LD Capsules on Day 15 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) on Day 15 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Levodopa Cmax Following First Dose on Day 15</title>
          <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
          <population>Randomized subjects who completed both periods</population>
          <units>ng/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="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2767.96" spread="1258.525"/>
                    <measurement group_id="O2" value="2356.85" spread="1178.628"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Levodopa Tmax Following First Dose on Day 15</title>
        <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
        <time_frame>Day 15</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participant who receive IPX203 ER CD-LD Capsules on Day 15 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) on Day 15 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Levodopa Tmax Following First Dose on Day 15</title>
          <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
          <population>Randomized subjects who completed both periods</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.91" spread="1.241"/>
                    <measurement group_id="O2" value="0.83" spread="0.439"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Levodopa AUCtau Following First Dose on Day 15</title>
        <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
        <time_frame>Day 15</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participant who receive IPX203 ER CD-LD Capsules on Day 15 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) on Day 15 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Levodopa AUCtau Following First Dose on Day 15</title>
          <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
          <population>Randomized subjects who completed both periods</population>
          <units>ng.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="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11213.76" spread="4887.246"/>
                    <measurement group_id="O2" value="3879.39" spread="1744.328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Carbidopa Cmax Following First Dose on Day 15</title>
        <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
        <time_frame>Day 15</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participant who receive IPX203 ER CD-LD Capsules on Day 15 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) on Day 15 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Carbidopa Cmax Following First Dose on Day 15</title>
          <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
          <population>Randomized subjects who completed both periods</population>
          <units>ng/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="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="478.66" spread="290.584"/>
                    <measurement group_id="O2" value="145.67" spread="82.541"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Carbidopa Tmax Following First Dose on Day 15</title>
        <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
        <time_frame>Day 15</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participant who receive IPX203 ER CD-LD Capsules on Day 15 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) on Day 15 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Carbidopa Tmax Following First Dose on Day 15</title>
          <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
          <population>Randomized subjects who completed both periods</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.52" spread="0.74"/>
                    <measurement group_id="O2" value="2.20" spread="0.639"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Carbidopa AUCtau Following First Dose on Day 15</title>
        <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
        <time_frame>Day 15</time_frame>
        <population>Randomized subjects who completed both periods</population>
        <group_list>
          <group group_id="O1">
            <title>IPX203</title>
            <description>Participant who receive IPX203 ER CD-LD Capsules on Day 15 of the study</description>
          </group>
          <group group_id="O2">
            <title>Sinemet</title>
            <description>Participants who received Sinemet (IR CD-LD) on Day 15 of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Carbidopa AUCtau Following First Dose on Day 15</title>
          <description>Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.</description>
          <population>Randomized subjects who completed both periods</population>
          <units>ng.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="27"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1892.39" spread="1017.537"/>
                    <measurement group_id="O2" value="415.83" spread="279.487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>15 days for each intervention plus 1 week washout up to a total of 37 days</time_frame>
      <desc>All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD</desc>
      <group_list>
        <group group_id="E1">
          <title>IPX203</title>
          <description>Participants received IPX203 ER CD-LD Capsules</description>
        </group>
        <group group_id="E2">
          <title>Sinemet</title>
          <description>Participant received Sinemet (IR CD-LD) Tablets</description>
        </group>
        <group group_id="E3">
          <title>Washout Period</title>
          <description>Washout between Period 1 and Period 2</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhorea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Non-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="10" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Upper respiratiory track infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Urinary Tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dystonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Occipital Neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Pamela Fitzpatrick, Director, Specialty Regulatory Affairs</name_or_title>
      <organization>Impax Laboratories, LLC</organization>
      <phone>631-633-2104</phone>
      <email>pfitzpatrick@amneal.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/NCT03007888
org study id: IPX203-B16-01
nct id: NCT03007888
lead sponsor: 
has dmc: Yes
Primary Objective:

      To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate
      release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).

      Secondary Objectives:

      To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.

      To compare the efficacy of IPX203 with IR CD-LD following multiple doses.

      To evaluate the safety of IPX203.
IPX203 is an investigational product containing CD-LD.

      IPX203-B16-01 Study Design:

      A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose
      crossover study.

      Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized.

      The study duration will be approximately 8 weeks, including the screening period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Levodopa Cmax Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Levodopa Tmax Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Levodopa t1/2 Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Levodopa AUCt Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Levodopa AUCinf Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Carbidopa Cmax Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Carbidopa Tmax Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Carbidopa t1/2 Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Carbidopa AUCt Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Carbidopa AUCinf Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
time frame: Day 1
description: Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
measure: Levodopa Cmax Following First Dose on Day 15
time frame: Day 15
description: Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
measure: Levodopa Tmax Following First Dose on Day 15
time frame: Day 15
description: Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
measure: Levodopa AUCtau Following First Dose on Day 15
time frame: Day 15
description: Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
measure: Carbidopa Cmax Following First Dose on Day 15
time frame: Day 15
description: Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
measure: Carbidopa Tmax Following First Dose on Day 15
time frame: Day 15
description: Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
measure: Carbidopa AUCtau Following First Dose on Day 15
time frame: Day 15
description: Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
arm group label: IPX203 then Sinemet
arm group type: Experimental
description: Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablet for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
arm group label: Sinemet then IPX203
arm group type: Experimental
description: Participants first received Sinemet Capsules for 15 days After a Washout Period of 7 days; participants then received IPX203 ER CD-LD Capsules for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
intervention type: Drug
intervention name: Sinemet
description: Immediate Release Tablet containing carbidopa-levodopa flexible dosing
arm group label: IPX203 then Sinemet
arm group label: Sinemet then IPX203
other name: IR CD-LD Tablets
intervention type: Drug
intervention name: IPX203
description: Extended Release capsules containing carbidopa-levodopa flexible dosing
arm group label: IPX203 then Sinemet
arm group label: Sinemet then IPX203
other name: IPX203 ER CD-LD Capsules
criteria: 
gender: All
minimum age: 40 Years
maximum age: 100 Years
healthy volunteers: No
last name: Impax Study Director
role: Study Director
affiliation: Impax Laboratories, LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Carbidopa, levodopa drug combination
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 