<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/NCT03292016</url>
  </required_header>
  <id_info>
    <org_study_id>CTH-203</org_study_id>
    <nct_id>NCT03292016</nct_id>
  </id_info>
  <brief_title>A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by &quot;OFF&quot; Episodes</brief_title>
  <official_title>A Comparative Bioavailability Study to Evaluate the Single Dose Pharmacokinetic Properties of APL-130277 With Two Different Formulations of Subcutaneous Apomorphine in a Randomized, 3-Period Crossover Design in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (&quot;OFF&quot; Episodes)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sumitomo Pharma America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sumitomo Pharma America, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study that compares the extent to which apomorphine becomes available in the body after&#xD;
      taking either an investigational drug containing apomorphine or apomorphine that is injected&#xD;
      under the skin in people with PD complicated by &quot;OFF&quot; episodes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multi-center study will aim to evaluate the pharmacokinetics (PK) and comparative&#xD;
      bioavailability of a single dose of APL-130277 sublingual thin film with subcutaneous (s.c.)&#xD;
      APO-go® and s.c. APOKYN® in subjects with Parkinson's disease (PD). The dose of APOKYN® (≤ 5&#xD;
      mg) will be based on the subjects' current prescribed dose. The study is designed as an&#xD;
      open-label, randomized, three-way crossover. Subjects will receive all three treatment arms&#xD;
      with a minimum 1-day wash-out between each visit (excluding the screening visit) and will be&#xD;
      randomly assigned to one of the six sequences&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Actual">March 5, 2019</completion_date>
  <primary_completion_date type="Actual">March 5, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Day 1</time_frame>
    <description>Dose normalized maximum observed plasma concentration (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Observed Time of the Maximum Concentration (Tmax)</measure>
    <time_frame>Day 1</time_frame>
    <description>Time from dosing to Cmax, observed by inspection of individual subject plots of plasma concentration versus time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration- Time Curve (AUC Last)</measure>
    <time_frame>Day 1</time_frame>
    <description>area under the concentration-time curve from time zero to the last measurable plasma concentration-time curve using the linear up log down trapezoidal rule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration- Time Curve (AUC Inf)</measure>
    <time_frame>Day 1</time_frame>
    <description>area under the concentration-time curve from time zero extrapolated to infinity using the linear up log down trapezoidal rule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Residence Time (MRT)</measure>
    <time_frame>Day 1</time_frame>
    <description>Mean residence time during one dosing interval calculated using the following equation: MRT = AUMCinf/AUC inf. AUMCinf is the area under the first moment (time.plasma concentration vs. time) curve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolite/Parent (M/P) Drug Concentration Ratio -Cmax</measure>
    <time_frame>Day 1</time_frame>
    <description>Metabolite (apomorphine sulfate) to Parent exposure ratio, Cmax, corrected for molecular weight differences.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F)</measure>
    <time_frame>Day 1</time_frame>
    <description>Apparent total clearance of the drug from plasma extravascular administration, calculated as Dose/AUCinf.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Volume of Distribution After Non-intravenous Administration (V/F)</measure>
    <time_frame>Day 1</time_frame>
    <description>Apparent volume of distribution after extravascular administration, calculated as Dose/(AUCinf * λz).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal-phase Half-life (t½)</measure>
    <time_frame>Day 1</time_frame>
    <description>Terminal phase half-life, as calculated by the following equation: t½ = ln(2)/λz.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal-phase Rate Constant ( λz)</measure>
    <time_frame>Day 1</time_frame>
    <description>Apparent terminal elimination rate constant, determined by log linear regression of the plasma concentration versus time data that was judged to be in the log-linear elimination phase. At least 3 data points in the terminal phase will be used in the determination of the rate constant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolite/Parent (M/P) Drug Concentration Ratio -AUC Last</measure>
    <time_frame>Day 1</time_frame>
    <description>Metabolite (apomorphine sulfate) to Parent exposure ratio, AUClast, corrected for molecular weight differences.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>APL-130277, sublingual thin film</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>APL-130277, sublingual thin film, once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subcutaneous APO-go</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneous APO-go, once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subcutaneous APOKYN</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subcutaneous APOKYN, once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>APL-130277</intervention_name>
    <description>APL-130277 sublingual thin film</description>
    <arm_group_label>APL-130277, sublingual thin film</arm_group_label>
    <other_name>amomorphine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>APO-go</intervention_name>
    <description>Subcutaneous APO-go</description>
    <arm_group_label>Subcutaneous APO-go</arm_group_label>
    <other_name>amomorphine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apokyn</intervention_name>
    <description>Subcutaneous APOKYN</description>
    <arm_group_label>Subcutaneous APOKYN</arm_group_label>
    <other_name>amomorphine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ≥ 18 years of age.&#xD;
&#xD;
          2. Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding&#xD;
             the &quot;more than one affected relative&quot; criterion).&#xD;
&#xD;
          3. Clinically meaningful response to Levodopa (L-Dopa) with well-defined &quot;OFF&quot; episodes,&#xD;
             as determined by the Investigator.&#xD;
&#xD;
          4. Receiving APOKYN® of ≤ 5 mg per dose for at least 4 weeks before the Screening Visit.&#xD;
&#xD;
          5. Receiving stable doses of L-Dopa/carbidopa (immediate or sustained release)&#xD;
             administered at least 4 times per day OR Rytary™ administered 3 times per day, for at&#xD;
             least 4 weeks before the Screening Visit. Adjunctive PD medication regimens must be&#xD;
             maintained at a stable dose for at least 4 weeks prior to the Screening Visit with the&#xD;
             exception that MAOB inhibitors must be maintained at a stable level for at least 8&#xD;
             weeks prior to the Screening Visit.&#xD;
&#xD;
          6. No planned medication change(s) or surgical intervention anticipated during the course&#xD;
             of study.&#xD;
&#xD;
          7. Patients must experience a well-defined &quot;OFF&quot; episode in the morning if they do not&#xD;
             take their morning PD medications on schedule, and must be willing to delay morning&#xD;
             doses on the 3 study dosing days&#xD;
&#xD;
          8. Stage III or less on the modified Hoehn and Yahr scale in the &quot;ON&quot; state.&#xD;
&#xD;
          9. Mini-Mental State Examination (MMSE) score &gt; 23.&#xD;
&#xD;
         10. If female and of childbearing potential, must agree to use one of the following&#xD;
             methods of birth control:&#xD;
&#xD;
               -  Oral contraceptive;&#xD;
&#xD;
               -  Contraceptive patch;&#xD;
&#xD;
               -  Barrier (diaphragm, sponge or condom) plus spermicidal preparations;&#xD;
&#xD;
               -  Intrauterine contraceptive system;&#xD;
&#xD;
               -  Levonorgestrel implant;&#xD;
&#xD;
               -  Medroxyprogesterone acetate contraceptive injection;&#xD;
&#xD;
               -  Complete abstinence from sexual intercourse;&#xD;
&#xD;
               -  Hormonal vaginal contraceptive ring; or&#xD;
&#xD;
               -  Surgical sterilization or partner sterile (must have documented proof).&#xD;
&#xD;
         11. Male patients must be either surgically sterile, agree to be sexually abstinent or use&#xD;
             a barrier method of birth control (e.g., condom) or maintain a monogamous relationship&#xD;
             with a person who is not of child-bearing potential from first study drug&#xD;
             administration until 30days after final drug administration.&#xD;
&#xD;
         12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,&#xD;
             and other study-related procedures to complete the study.&#xD;
&#xD;
         13. Able to understand the consent form, and to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Atypical or secondary parkinsonism.&#xD;
&#xD;
          2. Previous treatment with any of the following: continuous subcutaneous (s.c.)&#xD;
             apomorphine infusion; or Duodopa/Duopa.&#xD;
&#xD;
          3. Contraindications to APO-go® or APOKYN® or hypersensitivity to apomorphine&#xD;
             hydrochloride or any marcrolide antibiotic or any of the ingredients APO-go® or&#xD;
             APOKYN® (notably sodium metabisulfite).&#xD;
&#xD;
          4. Female who is pregnant or lactating.&#xD;
&#xD;
          5. Participation in a clinical trial within 30 days prior to the Screening Visit.&#xD;
&#xD;
          6. Receipt of any investigational (ie, unapproved) medication within 30 days prior to the&#xD;
             Screening Visit.&#xD;
&#xD;
          7. Any selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron,&#xD;
             palonosetron, alosetron), dopamine antagonists (excluding quetiapine and clozapine) or&#xD;
             dopamine depleting agents within 30 days prior to the Screening Visit.&#xD;
&#xD;
          8. Drug or alcohol dependency in the past 12 months.&#xD;
&#xD;
          9. History of malignant melanoma.&#xD;
&#xD;
         10. Clinically significant medical, surgical, or laboratory abnormality in the opinion of&#xD;
             the Investigator.&#xD;
&#xD;
         11. Major psychiatric disorder including, but not limited to, dementia, bipolar disorder,&#xD;
             psychosis, or any disorder that, in the opinion of the Investigator, requires ongoing&#xD;
             treatment that would make study participation unsafe or make treatment compliance&#xD;
             difficult.&#xD;
&#xD;
         12. History of clinically significant hallucinations during the past 6 months.&#xD;
&#xD;
         13. History of clinically significant impulse control disorder(s).&#xD;
&#xD;
         14. Dementia that precludes providing informed consent or would interfere with&#xD;
             participation in the study.&#xD;
&#xD;
         15. Current suicidal ideation within one year prior to the Screening Visit as evidenced by&#xD;
             answering &quot;yes&quot; to Questions 4 or 5 on the suicidal ideation portion of the&#xD;
             Columbia-Suicide Severity Rating Scale (C-SSRS) or attempted suicide within the last 5&#xD;
             years.&#xD;
&#xD;
         16. Donation of blood plasma in the 30 days prior to first dosing.&#xD;
&#xD;
         17. Cankers or mouth sores within 30 days prior to the Screening Visit, or other&#xD;
             clinically significant oral pathology in the opinion of the Investigator. The&#xD;
             Investigator should follow-up with an appropriate specialist on any finding, if&#xD;
             indicated, before enrolling a patient into the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CNS Mecdical Director</last_name>
    <role>Study Chair</role>
    <affiliation>Sunovion Pharmacetuicals Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parkinson's Disease and Movement Disorders Center of Boca Raton</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkinson's Disese Treatment Center of SW Florida</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33980</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QUEST Research Institute</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>June 20, 2020</results_first_submitted>
  <results_first_submitted_qc>August 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 13, 2020</results_first_posted>
  <disposition_first_submitted>November 21, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>August 11, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 13, 2020</disposition_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Off Episodes</keyword>
  <keyword>Parkinson Disease</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>Apomorphine</mesh_term>
  </intervention_browse>
  <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>May 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03292016/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>January 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03292016/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>APL-130277, Then APOKYN, Then APO-go</title>
          <description>Sequence 1: Participants first received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go ( same dose as APOKYN: 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.</description>
        </group>
        <group group_id="P2">
          <title>APL-130277, Then APO-go, Then APOKYN</title>
          <description>Sequence 2: Participants first received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.</description>
        </group>
        <group group_id="P3">
          <title>APOKYN, Then APL-130277, Then APO-go</title>
          <description>Sequence 3: Participants first received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.</description>
        </group>
        <group group_id="P4">
          <title>APOKYN, Then APO-go, Then APL-130277</title>
          <description>Sequence 4: Participants first received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state.</description>
        </group>
        <group group_id="P5">
          <title>APO-go, Then APL-130277, Then APOKYN</title>
          <description>Sequence 5: Participants first received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.</description>
        </group>
        <group group_id="P6">
          <title>APO-go, Then APOKYN, Then APL-130277</title>
          <description>Sequence 6: Participants first received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>First Washout</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Washout</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" 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="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Third Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>APL-130277, Then APOKYN, Then APO-go</title>
          <description>Sequence 1: Participants first received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go ( same dose as APOKYN: 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.</description>
        </group>
        <group group_id="B2">
          <title>APL-130277, Then APO-go, Then APOKYN</title>
          <description>Sequence 2: Participants first received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.</description>
        </group>
        <group group_id="B3">
          <title>APOKYN, Then APL-130277, Then APO-go</title>
          <description>Sequence 3: Participants first received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.</description>
        </group>
        <group group_id="B4">
          <title>APOKYN, Then APO-go, Then APL-130277</title>
          <description>Sequence 4: Participants first received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state.</description>
        </group>
        <group group_id="B5">
          <title>APO-go, Then APL-130277, Then APOKYN</title>
          <description>Sequence 5: Participants first received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state.</description>
        </group>
        <group group_id="B6">
          <title>APO-go, Then APOKYN, Then APL-130277</title>
          <description>Sequence 6: Participants first received APO-go (same dose as APOKYN 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APOKYN (current prescribed dose : 2 mg/3 mg/4mg/5 mg) in the 'OFF' state. After a washout period of at least one day, they received APL-130277 (approximate equivalent dose to current APOKYN dose: 15 mg/ 20 mg/ 25 mg/ 30 mg) in the 'OFF' state.</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="2"/>
            <count group_id="B4" value="1"/>
            <count group_id="B5" value="1"/>
            <count group_id="B6" value="2"/>
            <count group_id="B7" value="8"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="5"/>
                  </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="75"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="67.5" spread="9.19"/>
                    <measurement group_id="B4" value="67"/>
                    <measurement group_id="B5" value="73"/>
                    <measurement group_id="B6" value="68.5" spread="9.19"/>
                    <measurement group_id="B7" value="67.3" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="6"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" 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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Country</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>United States</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height (cm) at Baseline</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="172.7"/>
                    <measurement group_id="B2" value="157.5"/>
                    <measurement group_id="B3" value="174.95" spread="11.243"/>
                    <measurement group_id="B4" value="175.3"/>
                    <measurement group_id="B5" value="177.8"/>
                    <measurement group_id="B6" value="171.25" spread="19.445"/>
                    <measurement group_id="B7" value="171.96" spread="10.545"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Weight (kg) at Baseline</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86.3"/>
                    <measurement group_id="B2" value="59.4"/>
                    <measurement group_id="B3" value="86.7" spread="20.506"/>
                    <measurement group_id="B4" value="73"/>
                    <measurement group_id="B5" value="84.4"/>
                    <measurement group_id="B6" value="71.2" spread="25.032"/>
                    <measurement group_id="B7" value="77.36" spread="15.895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI (kg/m2) at Baseline</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.9"/>
                    <measurement group_id="B2" value="23.9"/>
                    <measurement group_id="B3" value="28.1" spread="3.111"/>
                    <measurement group_id="B4" value="23.8"/>
                    <measurement group_id="B5" value="26.7"/>
                    <measurement group_id="B6" value="23.8" spread="3.111"/>
                    <measurement group_id="B7" value="25.89" spread="2.826"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ON State Mod. Hoehn &amp; Yahr Score</title>
          <description>The modified Hoehn and Yahr Scale (HYS) provides a global assessment of severity in Parkinson's Disease based on clinical findings and functional disability.•Stage 0:(No signs of disease, through Stage 5: Wheelchair bound or bedridden unless aided.&#xD;
Higher rates describe an increase severity of the disease.</description>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2.5" spread="0"/>
                    <measurement group_id="B4" value="2.5"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="2.5" spread="0.707"/>
                    <measurement group_id="B7" value="2.44" spread="0.417"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mini-Mental Status Total Score</title>
          <description>Mini-Mental State Examination (MMSE) is used to evaluate a person's cognitive and mental function. Score range is 0-30 with lower scores showing higher impairment.</description>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="26.5" spread="2.12"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="27"/>
                    <measurement group_id="B6" value="27.5" spread="3.54"/>
                    <measurement group_id="B7" value="27.5" spread="2.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Child-bearing potential</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>N/A</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Has never smoked</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Former Smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax)</title>
        <description>Dose normalized maximum observed plasma concentration (Cmax)</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>APL-130277, Sublingual Thin Film</title>
            <description>APL-130277, sublingual thin film, once daily</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous APOKYN</title>
            <description>Subcutaneous APOKYN, once daily</description>
          </group>
          <group group_id="O3">
            <title>Subcutaneous APO-go</title>
            <description>Subcutaneous APO-go, once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax)</title>
          <description>Dose normalized maximum observed plasma concentration (Cmax)</description>
          <units>(ng/mL)/(mg)</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.281" lower_limit="0.191" upper_limit="0.413"/>
                    <measurement group_id="O2" value="2.29" lower_limit="1.46" upper_limit="3.59"/>
                    <measurement group_id="O3" value="2.74" lower_limit="1.82" upper_limit="4.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Sample size of 12 subjects, a two-sided 90% CI for the difference in paired PK parameter means on the log scale will have an interval that extends no more than 0.221 units from the observed difference with 90% coverage probability. Assumes CV of 35% for the difference on the original scale.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric Mean ratio (APL-130277/APOKYN)</param_type>
            <param_value>12.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.5</ci_lower_limit>
            <ci_upper_limit>20.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric Mean ratio (APL-130277/APO-go)</param_type>
            <param_value>10.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.5</ci_lower_limit>
            <ci_upper_limit>16.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>relative bioavailibilty</non_inferiority_desc>
            <param_type>Geometric Mean ratio (APOKYN/APO-go)</param_type>
            <param_value>83.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>50.5</ci_lower_limit>
            <ci_upper_limit>137.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.21</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.13</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>1.16</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.16</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.17</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>1.12</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.08</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.09</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>1.04</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Observed Time of the Maximum Concentration (Tmax)</title>
        <description>Time from dosing to Cmax, observed by inspection of individual subject plots of plasma concentration versus time.</description>
        <time_frame>Day 1</time_frame>
        <population>Tmax summary statistics were summarized by dose levels and the inferential statistics was done across all dose levels.</population>
        <group_list>
          <group group_id="O1">
            <title>APL-130277, Sublingual Thin Film</title>
            <description>APL-130277, sublingual thin film, once daily</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous APOKYN</title>
            <description>Subcutaneous APOKYN, once daily</description>
          </group>
          <group group_id="O3">
            <title>Subcutaneous APO-go</title>
            <description>Subcutaneous APO-go, once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Observed Time of the Maximum Concentration (Tmax)</title>
          <description>Time from dosing to Cmax, observed by inspection of individual subject plots of plasma concentration versus time.</description>
          <population>Tmax summary statistics were summarized by dose levels and the inferential statistics was done across all dose levels.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>APL 20 mg, APOKYN 3 mg, and APO-go 3 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" lower_limit="0.52" upper_limit="0.75"/>
                    <measurement group_id="O2" value="0.38" lower_limit="0.25" upper_limit="0.50"/>
                    <measurement group_id="O3" value="0.38" lower_limit="0.25" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 25 mg, APOKYN 4 mg, and APO-go 4 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" lower_limit="0.25" upper_limit="1.02"/>
                    <measurement group_id="O2" value="0.25" lower_limit="0.25" upper_limit="0.25"/>
                    <measurement group_id="O3" value="0.26" lower_limit="0.25" upper_limit="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 30 mg, APOKYN 5 mg, and APO-go 5 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" lower_limit="0.50" upper_limit="1.00"/>
                    <measurement group_id="O2" value="0.38" lower_limit="0.25" upper_limit="0.50"/>
                    <measurement group_id="O3" value="0.25" lower_limit="0.25" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0625</p_value>
            <method>Sign test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0313</p_value>
            <method>Sign test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.9999</p_value>
            <method>Sign test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration- Time Curve (AUC Last)</title>
        <description>area under the concentration-time curve from time zero to the last measurable plasma concentration-time curve using the linear up log down trapezoidal rule.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>APL-130277, Sublingual Thin Film</title>
            <description>APL-130277, sublingual thin film, once daily</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous APOKYN</title>
            <description>Subcutaneous APOKYN, once daily</description>
          </group>
          <group group_id="O3">
            <title>Subcutaneous APO-go</title>
            <description>Subcutaneous APO-go, once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration- Time Curve (AUC Last)</title>
          <description>area under the concentration-time curve from time zero to the last measurable plasma concentration-time curve using the linear up log down trapezoidal rule.</description>
          <units>(hxng/mL)/(mg)</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.344" upper_limit="0.726"/>
                    <measurement group_id="O2" value="2.91" lower_limit="1.97" upper_limit="4.30"/>
                    <measurement group_id="O3" value="3.00" lower_limit="2.05" upper_limit="4.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric Mean Ratio (APL-130277/APOKYN)</param_type>
            <param_value>17.2</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.1</ci_lower_limit>
            <ci_upper_limit>22.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric Mean Ratio (APL-130277/APOKYN)</param_type>
            <param_value>16.7</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.0</ci_lower_limit>
            <ci_upper_limit>21.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric Mean Ratio (APOKYN/APO-go)</param_type>
            <param_value>96.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>74.2</ci_lower_limit>
            <ci_upper_limit>126.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.32</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.16</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>1.09</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.23</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.23</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>1.00</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.15</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.14</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Ratio</param_type>
            <param_value>0.96</param_value>
            <estimate_desc>The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration- Time Curve (AUC Inf)</title>
        <description>area under the concentration-time curve from time zero extrapolated to infinity using the linear up log down trapezoidal rule.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>APL-130277, Sublingual Thin Film</title>
            <description>APL-130277, sublingual thin film, once daily</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous APOKYN</title>
            <description>Subcutaneous APOKYN, once daily</description>
          </group>
          <group group_id="O3">
            <title>Subcutaneous APO-go</title>
            <description>Subcutaneous APO-go, once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration- Time Curve (AUC Inf)</title>
          <description>area under the concentration-time curve from time zero extrapolated to infinity using the linear up log down trapezoidal rule.</description>
          <units>(hxng/mL)/(mg)</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" lower_limit="0.36" upper_limit="0.76"/>
                    <measurement group_id="O2" value="2.97" lower_limit="2.01" upper_limit="4.39"/>
                    <measurement group_id="O3" value="3.04" lower_limit="2.08" upper_limit="4.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric Mean Ratio (APL-130277/APOKYN)</param_type>
            <param_value>17.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.7</ci_lower_limit>
            <ci_upper_limit>22.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric Mean Ratio (APL-130277/APO-go)</param_type>
            <param_value>17.2</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.7</ci_lower_limit>
            <ci_upper_limit>21.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric Mean Ratio (APOKYN/APO-go)</param_type>
            <param_value>97.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>76.6</ci_lower_limit>
            <ci_upper_limit>124.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Residence Time (MRT)</title>
        <description>Mean residence time during one dosing interval calculated using the following equation: MRT = AUMCinf/AUC inf. AUMCinf is the area under the first moment (time.plasma concentration vs. time) curve.</description>
        <time_frame>Day 1</time_frame>
        <population>MRT was summarized by dose level</population>
        <group_list>
          <group group_id="O1">
            <title>APL-130277, Sublingual Thin Film</title>
            <description>APL-130277, sublingual thin film, once daily</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous APOKYN</title>
            <description>Subcutaneous APOKYN, once daily</description>
          </group>
          <group group_id="O3">
            <title>Subcutaneous APO-go</title>
            <description>Subcutaneous APO-go, once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Residence Time (MRT)</title>
          <description>Mean residence time during one dosing interval calculated using the following equation: MRT = AUMCinf/AUC inf. AUMCinf is the area under the first moment (time.plasma concentration vs. time) curve.</description>
          <population>MRT was summarized by dose level</population>
          <units>h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>APL 20 mg, APOKYN 3 mg, and APO-go 3 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.69" spread="5.2"/>
                    <measurement group_id="O2" value="1.44" spread="4.3"/>
                    <measurement group_id="O3" value="1.21" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 25 mg, APOKYN 4 mg, and APO-go 4 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.83" spread="41.5"/>
                    <measurement group_id="O2" value="1.70" spread="13.8"/>
                    <measurement group_id="O3" value="1.51" spread="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 30 mg, APOKYN 5 mg, and APO-go 5 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.15" spread="15.9"/>
                    <measurement group_id="O2" value="1.23" spread="3.4"/>
                    <measurement group_id="O3" value="1.08" spread="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Metabolite/Parent (M/P) Drug Concentration Ratio -Cmax</title>
        <description>Metabolite (apomorphine sulfate) to Parent exposure ratio, Cmax, corrected for molecular weight differences.</description>
        <time_frame>Day 1</time_frame>
        <population>Metabolite/Parent Cmax summarized by dose level</population>
        <group_list>
          <group group_id="O1">
            <title>APL-130277, Sublingual Thin Film</title>
            <description>APL-130277, sublingual thin film, once daily</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous APOKYN</title>
            <description>Subcutaneous APOKYN, once daily</description>
          </group>
          <group group_id="O3">
            <title>Subcutaneous APO-go</title>
            <description>Subcutaneous APO-go, once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Metabolite/Parent (M/P) Drug Concentration Ratio -Cmax</title>
          <description>Metabolite (apomorphine sulfate) to Parent exposure ratio, Cmax, corrected for molecular weight differences.</description>
          <population>Metabolite/Parent Cmax summarized by dose level</population>
          <units>no unit</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>APL 20 mg, APOKYN 3 mg and APO-go 3 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.6" spread="28.8"/>
                    <measurement group_id="O2" value="15.2" spread="48.9"/>
                    <measurement group_id="O3" value="11.5" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 25 mg, APOKYN 4 mg and APO-go 4 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0" spread="157.1"/>
                    <measurement group_id="O2" value="9.0" spread="149.3"/>
                    <measurement group_id="O3" value="7.1" spread="240.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 30 mg, APOKYN 5 mg and APO-go 5 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.2" spread="87.0"/>
                    <measurement group_id="O2" value="13.7" spread="8.2"/>
                    <measurement group_id="O3" value="11.3" spread="47.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F)</title>
        <description>Apparent total clearance of the drug from plasma extravascular administration, calculated as Dose/AUCinf.</description>
        <time_frame>Day 1</time_frame>
        <population>CL/F summarized by dose level</population>
        <group_list>
          <group group_id="O1">
            <title>APL-130277, Sublingual Thin Film</title>
            <description>APL-130277, sublingual thin film, once daily</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous APOKYN</title>
            <description>Subcutaneous APOKYN, once daily</description>
          </group>
          <group group_id="O3">
            <title>Subcutaneous APO-go</title>
            <description>Subcutaneous APO-go, once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F)</title>
          <description>Apparent total clearance of the drug from plasma extravascular administration, calculated as Dose/AUCinf.</description>
          <population>CL/F summarized by dose level</population>
          <units>L/h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>APL 20 mg, APOKYN 3 mg and APO-go 3 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2766.9" spread="52.4"/>
                    <measurement group_id="O2" value="407.9" spread="33.3"/>
                    <measurement group_id="O3" value="375.6" spread="32.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 25 mg, APOKYN 4 mg and APO-go 4 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1097.8" spread="99.5"/>
                    <measurement group_id="O2" value="250.2" spread="140.6"/>
                    <measurement group_id="O3" value="253.7" spread="169.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 30 mg, APOKYN 5 mg and APO-go 5 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1952.1" spread="44.3"/>
                    <measurement group_id="O2" value="350.6" spread="4.0"/>
                    <measurement group_id="O3" value="299.2" spread="41.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Volume of Distribution After Non-intravenous Administration (V/F)</title>
        <description>Apparent volume of distribution after extravascular administration, calculated as Dose/(AUCinf * λz).</description>
        <time_frame>Day 1</time_frame>
        <population>V/F summarized by dose level</population>
        <group_list>
          <group group_id="O1">
            <title>APL-130277, Sublingual Thin Film</title>
            <description>APL-130277, sublingual thin film, once daily</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous APOKYN</title>
            <description>Subcutaneous APOKYN, once daily</description>
          </group>
          <group group_id="O3">
            <title>Subcutaneous APO-go</title>
            <description>Subcutaneous APO-go, once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution After Non-intravenous Administration (V/F)</title>
          <description>Apparent volume of distribution after extravascular administration, calculated as Dose/(AUCinf * λz).</description>
          <population>V/F summarized by dose level</population>
          <units>L</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>APL 20 mg, APOKYN 3 mg and APO-go 3 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4440.2" spread="72.0"/>
                    <measurement group_id="O2" value="577.5" spread="44.3"/>
                    <measurement group_id="O3" value="469.3" spread="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 25 mg, APOKYN 4 mg and APO-go 4 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1733.4" spread="52.8"/>
                    <measurement group_id="O2" value="420.8" spread="193.7"/>
                    <measurement group_id="O3" value="372.2" spread="231.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 30 mg, APOKYN 5 mg and APO-go 5 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3419.5" spread="67.4"/>
                    <measurement group_id="O2" value="452.0" spread="14.7"/>
                    <measurement group_id="O3" value="324.2" spread="73.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Terminal-phase Half-life (t½)</title>
        <description>Terminal phase half-life, as calculated by the following equation: t½ = ln(2)/λz.</description>
        <time_frame>Day 1</time_frame>
        <population>Terminal-phase half-life summarized by dose level</population>
        <group_list>
          <group group_id="O1">
            <title>APL-130277, Sublingual Thin Film</title>
            <description>APL-130277, sublingual thin film, once daily</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous APOKYN</title>
            <description>Subcutaneous APOKYN, once daily</description>
          </group>
          <group group_id="O3">
            <title>Subcutaneous APO-go</title>
            <description>Subcutaneous APO-go, once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal-phase Half-life (t½)</title>
          <description>Terminal phase half-life, as calculated by the following equation: t½ = ln(2)/λz.</description>
          <population>Terminal-phase half-life summarized by dose level</population>
          <units>h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>APL 20 mg, APOKYN 3 mg and APO-go 3 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.11" spread="15.6"/>
                    <measurement group_id="O2" value="0.98" spread="9.9"/>
                    <measurement group_id="O3" value="0.87" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 25 mg, APOKYN 4 mg and APO-go 4 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.09" spread="34.3"/>
                    <measurement group_id="O2" value="1.17" spread="20.6"/>
                    <measurement group_id="O3" value="1.02" spread="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 30 mg, APOKYN 5 mg and APO-go 5 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" spread="20.5"/>
                    <measurement group_id="O2" value="0.89" spread="18.7"/>
                    <measurement group_id="O3" value="0.75" spread="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0313</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0625</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.9999</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Terminal-phase Rate Constant ( λz)</title>
        <description>Apparent terminal elimination rate constant, determined by log linear regression of the plasma concentration versus time data that was judged to be in the log-linear elimination phase. At least 3 data points in the terminal phase will be used in the determination of the rate constant.</description>
        <time_frame>Day 1</time_frame>
        <population>terminal-phase rate constant summarized by dose level</population>
        <group_list>
          <group group_id="O1">
            <title>APL-130277, Sublingual Thin Film</title>
            <description>APL-130277, sublingual thin film, once daily</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous APOKYN</title>
            <description>Subcutaneous APOKYN, once daily</description>
          </group>
          <group group_id="O3">
            <title>Subcutaneous APO-go</title>
            <description>Subcutaneous APO-go, once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal-phase Rate Constant ( λz)</title>
          <description>Apparent terminal elimination rate constant, determined by log linear regression of the plasma concentration versus time data that was judged to be in the log-linear elimination phase. At least 3 data points in the terminal phase will be used in the determination of the rate constant.</description>
          <population>terminal-phase rate constant summarized by dose level</population>
          <units>/h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>APL 20 mg, APOKYN 3 mg and APO-go 3 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62" spread="15.6"/>
                    <measurement group_id="O2" value="0.71" spread="9.9"/>
                    <measurement group_id="O3" value="0.80" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 25 mg, APOKYN 4 mg and APO-go 4 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="34.3"/>
                    <measurement group_id="O2" value="0.59" spread="20.6"/>
                    <measurement group_id="O3" value="0.68" spread="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 30 mg, APOKYN 5 mg and APO-go 5 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" spread="20.5"/>
                    <measurement group_id="O2" value="0.78" spread="18.7"/>
                    <measurement group_id="O3" value="0.92" spread="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Metabolite/Parent (M/P) Drug Concentration Ratio -AUC Last</title>
        <description>Metabolite (apomorphine sulfate) to Parent exposure ratio, AUClast, corrected for molecular weight differences.</description>
        <time_frame>Day 1</time_frame>
        <population>Metabolite/Parent (M/P) drug concentration Ratio -AUC last summarized by dose level</population>
        <group_list>
          <group group_id="O1">
            <title>APL-130277, Sublingual Thin Film</title>
            <description>APL-130277, sublingual thin film, once daily</description>
          </group>
          <group group_id="O2">
            <title>Subcutaneous APOKYN</title>
            <description>Subcutaneous APOKYN, once daily</description>
          </group>
          <group group_id="O3">
            <title>Subcutaneous APO-go</title>
            <description>Subcutaneous APO-go, once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Metabolite/Parent (M/P) Drug Concentration Ratio -AUC Last</title>
          <description>Metabolite (apomorphine sulfate) to Parent exposure ratio, AUClast, corrected for molecular weight differences.</description>
          <population>Metabolite/Parent (M/P) drug concentration Ratio -AUC last summarized by dose level</population>
          <units>no unit</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>APL 20 mg, APOKYN 3 mg and APO-go 3 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.16" spread="6.4"/>
                    <measurement group_id="O2" value="36.22" spread="3.0"/>
                    <measurement group_id="O3" value="32.19" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 25 mg, APOKYN 4 mg and APO-go 4 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.79" spread="169.9"/>
                    <measurement group_id="O2" value="18.70" spread="162.8"/>
                    <measurement group_id="O3" value="16.27" spread="221.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APL 30 mg, APOKYN 5 mg and APO-go 5 mg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.07" spread="55.4"/>
                    <measurement group_id="O2" value="33.63" spread="6.2"/>
                    <measurement group_id="O3" value="26.22" spread="43.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>APL-130277, Sublingual Thin Film</title>
          <description>APL-130277, sublingual thin film, once daily</description>
        </group>
        <group group_id="E2">
          <title>Subcutaneous APOKYN</title>
          <description>Subcutaneous APOKYN, once daily</description>
        </group>
        <group group_id="E3">
          <title>Subcutaneous APO-go</title>
          <description>Subcutaneous APO-go, once daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Splenic rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </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>In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>CNS Medical Director</name_or_title>
      <organization>Sunovion Pharmaceuticals Inc.</organization>
      <phone>1-866-503-6351</phone>
      <email>clinicaltrialsdisclosure@sunovion.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/NCT03292016
org study id: CTH-203
nct id: NCT03292016
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A study that compares the extent to which apomorphine becomes available in the body after
      taking either an investigational drug containing apomorphine or apomorphine that is injected
      under the skin in people with PD complicated by "OFF" episodes.
This multi-center study will aim to evaluate the pharmacokinetics (PK) and comparative
      bioavailability of a single dose of APL-130277 sublingual thin film with subcutaneous (s.c.)
      APO-go® and s.c. APOKYN® in subjects with Parkinson's disease (PD). The dose of APOKYN® (≤ 5
      mg) will be based on the subjects' current prescribed dose. The study is designed as an
      open-label, randomized, three-way crossover. Subjects will receive all three treatment arms
      with a minimum 1-day wash-out between each visit (excluding the screening visit) and will be
      randomly assigned to one of the six sequences
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Day 1
description: Dose normalized maximum observed plasma concentration (Cmax)
measure: Observed Time of the Maximum Concentration (Tmax)
time frame: Day 1
description: Time from dosing to Cmax, observed by inspection of individual subject plots of plasma concentration versus time.
measure: Area Under the Concentration- Time Curve (AUC Last)
time frame: Day 1
description: area under the concentration-time curve from time zero to the last measurable plasma concentration-time curve using the linear up log down trapezoidal rule.
measure: Area Under the Concentration- Time Curve (AUC Inf)
time frame: Day 1
description: area under the concentration-time curve from time zero extrapolated to infinity using the linear up log down trapezoidal rule.
measure: Mean Residence Time (MRT)
time frame: Day 1
description: Mean residence time during one dosing interval calculated using the following equation: MRT = AUMCinf/AUC inf. AUMCinf is the area under the first moment (time.plasma concentration vs. time) curve.
measure: Metabolite/Parent (M/P) Drug Concentration Ratio -Cmax
time frame: Day 1
description: Metabolite (apomorphine sulfate) to Parent exposure ratio, Cmax, corrected for molecular weight differences.
measure: Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F)
time frame: Day 1
description: Apparent total clearance of the drug from plasma extravascular administration, calculated as Dose/AUCinf.
measure: Apparent Volume of Distribution After Non-intravenous Administration (V/F)
time frame: Day 1
description: Apparent volume of distribution after extravascular administration, calculated as Dose/(AUCinf * λz).
measure: Terminal-phase Half-life (t½)
time frame: Day 1
description: Terminal phase half-life, as calculated by the following equation: t½ = ln(2)/λz.
measure: Terminal-phase Rate Constant ( λz)
time frame: Day 1
description: Apparent terminal elimination rate constant, determined by log linear regression of the plasma concentration versus time data that was judged to be in the log-linear elimination phase. At least 3 data points in the terminal phase will be used in the determination of the rate constant.
measure: Metabolite/Parent (M/P) Drug Concentration Ratio -AUC Last
time frame: Day 1
description: Metabolite (apomorphine sulfate) to Parent exposure ratio, AUClast, corrected for molecular weight differences.
arm group label: APL-130277, sublingual thin film
arm group type: Experimental
description: APL-130277, sublingual thin film, once daily
arm group label: Subcutaneous APO-go
arm group type: Active Comparator
description: Subcutaneous APO-go, once daily
arm group label: Subcutaneous APOKYN
arm group type: Active Comparator
description: Subcutaneous APOKYN, once daily
intervention type: Drug
intervention name: APL-130277
description: APL-130277 sublingual thin film
arm group label: APL-130277, sublingual thin film
other name: amomorphine
intervention type: Drug
intervention name: APO-go
description: Subcutaneous APO-go
arm group label: Subcutaneous APO-go
other name: amomorphine
intervention type: Drug
intervention name: Apokyn
description: Subcutaneous APOKYN
arm group label: Subcutaneous APOKYN
other name: amomorphine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: CNS Mecdical Director
role: Study Chair
affiliation: Sunovion Pharmacetuicals Inc.
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Apomorphine
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 