<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/NCT02196714</url>
  </required_header>
  <id_info>
    <org_study_id>PT003010-00</org_study_id>
    <nct_id>NCT02196714</nct_id>
  </id_info>
  <brief_title>PK Study of PT003 and PT001 in Japanese Healthy Subjects</brief_title>
  <official_title>A Phase I, Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001 in Japanese Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pearl Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pearl Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over,&#xD;
      Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the&#xD;
      Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-12</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-12</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-t</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-t</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-∞</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC 0-∞</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T 1/2</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T 1/2</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vd/F</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vd/F</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lambda z</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lambda z</measure>
    <time_frame>Day 1</time_frame>
    <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</measure>
    <time_frame>12 Hours</time_frame>
    <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</measure>
    <time_frame>12 Hours</time_frame>
    <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</measure>
    <time_frame>12 Hours</time_frame>
    <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</measure>
    <time_frame>12 Hours</time_frame>
    <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</measure>
    <time_frame>12 hours</time_frame>
    <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</measure>
    <time_frame>12 hours</time_frame>
    <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</measure>
    <time_frame>12 hours</time_frame>
    <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose</measure>
    <time_frame>12 hours</time_frame>
    <description>Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Heart Rate From Pre-dose to 12 Hours Post Dose</measure>
    <time_frame>12 hours</time_frame>
    <description>Change in Heart Rate from Pre-dose to 12 hours Post dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PR Interval From Pre-dose to 12 Hours Post Dose</measure>
    <time_frame>12 hours</time_frame>
    <description>Change in PR Interval from Pre-dose to 12 hours Post dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QRS Axis From Pre-dose to 12 Hours Post Dose</measure>
    <time_frame>12 hours</time_frame>
    <description>Change in QRS axis from Pre-dose to 12 hours Post dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QRS Duration From Pre-dose to 12 Hours Post Dose</measure>
    <time_frame>12 hours</time_frame>
    <description>Change in QRS duration from Pre-dose to 12 hours Post dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QT Interval From Pre-dose to 12 Hours Post Dose</measure>
    <time_frame>12 hours</time_frame>
    <description>Change in QT Interval from Pre-dose to 12 hours Post dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose</measure>
    <time_frame>12 hours</time_frame>
    <description>Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose</measure>
    <time_frame>12 hours</time_frame>
    <description>Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Glycopyrronium and Formoterol Fumarate (GFF) Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glycopyrronium and Formoterol Fumarate (GFF) Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glycopyrronium (GP) Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glycopyrronium (GP) Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glycopyrronium and Formoterol Fumarate (GFF) Dose 1</intervention_name>
    <description>Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)</description>
    <arm_group_label>Glycopyrronium and Formoterol Fumarate (GFF) Dose 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glycopyrronium and Formoterol Fumarate (GFF) Dose 2</intervention_name>
    <description>Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)</description>
    <arm_group_label>Glycopyrronium and Formoterol Fumarate (GFF) Dose 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glycopyrronium (GP) Dose 1</intervention_name>
    <description>Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)</description>
    <arm_group_label>Glycopyrronium (GP) Dose 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glycopyrronium (GP) Dose 2</intervention_name>
    <description>Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)</description>
    <arm_group_label>Glycopyrronium (GP) Dose 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Informed Consent Form (ICF) prior to any study related procedures&#xD;
&#xD;
          -  Male and female first generation Japanese subjects 18 to 45 years, inclusive&#xD;
&#xD;
          -  Good general health&#xD;
&#xD;
          -  Medically acceptable contraception for women of child-bearing potential and males with&#xD;
             female partners of childbearing potential&#xD;
&#xD;
          -  Clinical labs within normal ranges or determined to be not clinically significant by&#xD;
             the Investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, nursing female subjects, or subjects trying to conceive&#xD;
&#xD;
          -  Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic,&#xD;
             pulmonary, hematological, psychiatric, or other medical illness that would interfere&#xD;
             with participation in this study&#xD;
&#xD;
          -  History of ECG abnormalities&#xD;
&#xD;
          -  Cancer not in complete remission for at least 5 years&#xD;
&#xD;
          -  Clinically significant, symptomatic prostatic hypertrophy&#xD;
&#xD;
          -  Male subjects with a trans-urethral resection of the prostate or full resection of the&#xD;
             prostate within 6 months prior to Screening&#xD;
&#xD;
          -  Clinically significant bladder neck obstruction or urinary retention&#xD;
&#xD;
          -  Inadequately treated glaucoma&#xD;
&#xD;
          -  History of an allergic reaction or hypersensitivity to any drug or to any component of&#xD;
             the formulations used in this study&#xD;
&#xD;
          -  Subjects with pre-existing anemia and/or iron deficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chadwick Orevillo</last_name>
    <role>Study Chair</role>
    <affiliation>Pearl Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SNBL</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>May 24, 2016</results_first_submitted>
  <results_first_submitted_qc>March 14, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 26, 2017</results_first_posted>
  <last_update_submitted>March 14, 2017</last_update_submitted>
  <last_update_submitted_qc>March 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Japanese Healthy Volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glycopyrrolate</mesh_term>
    <mesh_term>Formoterol Fumarate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Conducted at 1 site from July 2014 - September 2014. Study duration for each subject was between 33 and 98 days.</recruitment_details>
      <pre_assignment_details>Study was four-period, four-treatment, complete cross-over design in healthy adult Japanese Subjects. Each treatment visit was followed by a minimum 7 day to maximum 14 day washout period between treatments.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Received GFF MDI 28.8/9.6 μg</title>
          <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 μg</description>
        </group>
        <group group_id="P2">
          <title>Received GFF MDI 14.4/9.6 μg</title>
          <description>Received GFF MDI 14.4/9.6 μg</description>
        </group>
        <group group_id="P3">
          <title>Received GP MDI 28.8 μg</title>
          <description>Glycopyrronium (GP) Metered Dose Inhaler (MDI) 28.8 μg</description>
        </group>
        <group group_id="P4">
          <title>Received GP MDI 14.4 μg</title>
          <description>Received GP MDI 14.4 μg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis Set: All Subjects Randomized</population>
      <group_list>
        <group group_id="B1">
          <title>All Subjects</title>
          <description>Analysis Set: All Subjects Randomized</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="29.8" spread="6.5"/>
                  </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="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cmax</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
          <group group_id="O4">
            <title>GP MDI 14.4 µg</title>
            <description>GP MDI 14.4 µg</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.23" spread="7.69" lower_limit="2.11" upper_limit="38.80"/>
                    <measurement group_id="O2" value="9.09" spread="6.5" lower_limit="2.25" upper_limit="27.80"/>
                    <measurement group_id="O3" value="16.85" spread="4.26" lower_limit="4.09" upper_limit="56.40"/>
                    <measurement group_id="O4" value="7.26" lower_limit="2.51" upper_limit="16.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.74" spread="3.46" lower_limit="3.18" upper_limit="16.20"/>
                    <measurement group_id="O2" value="11.99" spread="7.07" lower_limit="3.95" upper_limit="30.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-12</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
          <group group_id="O4">
            <title>GP MDI 14.4 ug</title>
            <description>GP MDI 14.4 ug</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-12</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>h*pg/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.43" spread="19.43" lower_limit="11.31" upper_limit="83.76"/>
                    <measurement group_id="O2" value="21.75" spread="9.00" lower_limit="3.71" upper_limit="43.16"/>
                    <measurement group_id="O3" value="50.59" spread="10.75" lower_limit="13.57" upper_limit="108.54"/>
                    <measurement group_id="O4" value="24.72" lower_limit="7.63" upper_limit="51.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-12</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-12</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>h*pg/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.15" spread="15.3" lower_limit="10.59" upper_limit="79.35"/>
                    <measurement group_id="O2" value="42.54" spread="12.04" lower_limit="17.88" upper_limit="62.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-t</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
          <group group_id="O4">
            <title>GP MDI 14.4 µg</title>
            <description>GP MDI 14.4 µg</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-t</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>h*pg/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.52" spread="3.31" lower_limit="7.11" upper_limit="122.09"/>
                    <measurement group_id="O2" value="21.37" spread="14.53" lower_limit="1.49" upper_limit="58.08"/>
                    <measurement group_id="O3" value="64.05" spread="17.61" lower_limit="9.69" upper_limit="146.37"/>
                    <measurement group_id="O4" value="23.72" lower_limit="5.27" upper_limit="68.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-t</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-t</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>h*pg/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.96" spread="19.85" lower_limit="7.94" upper_limit="107.41"/>
                    <measurement group_id="O2" value="42.39" spread="14.69" lower_limit="14.93" upper_limit="69.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-∞</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 µg</title>
            <description>GP MDI 28.8 µg</description>
          </group>
          <group group_id="O4">
            <title>GP MDI 14.4 µg</title>
            <description>GP MDI 14.4 µg</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-∞</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>h*pg/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.26" lower_limit="29.58" upper_limit="60.11"/>
                    <measurement group_id="O2" value="32.18" lower_limit="30.24" upper_limit="34.13"/>
                    <measurement group_id="O3" value="37.32" lower_limit="32.36" upper_limit="42.28"/>
                    <measurement group_id="O4" value="34.04" lower_limit="33.67" upper_limit="34.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC 0-∞</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-∞</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>h*pg/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.88" spread="21.60" lower_limit="41.27" upper_limit="126.07"/>
                    <measurement group_id="O2" value="61.43" spread="12.01" lower_limit="45.43" upper_limit="82.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
          <group group_id="O4">
            <title>GP MDI 14.4 ug</title>
            <description>GP MDI 14.4 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)</description>
          <population>Pharmacokinetic Population</population>
          <units>h</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" lower_limit="0.03" upper_limit="4.02"/>
                    <measurement group_id="O2" value="0.10" lower_limit="0.03" upper_limit="0.10"/>
                    <measurement group_id="O3" value="0.10" lower_limit="0.03" upper_limit="2.00"/>
                    <measurement group_id="O4" value="0.10" lower_limit="0.03" upper_limit="4.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)</description>
          <population>Pharmacokinetic Population</population>
          <units>h</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" lower_limit="0.10" upper_limit="1.00"/>
                    <measurement group_id="O2" value="0.10" lower_limit="0.10" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>T 1/2</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
          <group group_id="O4">
            <title>GP MDI 14.4 ug</title>
            <description>GP MDI 14.4 ug</description>
          </group>
        </group_list>
        <measure>
          <title>T 1/2</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>h</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.49" spread="11.98" lower_limit="2.88" upper_limit="37.90"/>
                    <measurement group_id="O2" value="4.14" spread="1.40" lower_limit="1.31" upper_limit="6.89"/>
                    <measurement group_id="O3" value="24.87" spread="51.77" lower_limit="2.14" upper_limit="103.21"/>
                    <measurement group_id="O4" value="19.13" lower_limit="2.08" upper_limit="191.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>T 1/2</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
        </group_list>
        <measure>
          <title>T 1/2</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>h</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.45" spread="2.39" lower_limit="3.11" upper_limit="14.36"/>
                    <measurement group_id="O2" value="5.25" spread="2.32" lower_limit="3.24" upper_limit="13.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CL/F</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 µg</title>
            <description>GP MDI 28.8 µg</description>
          </group>
          <group group_id="O4">
            <title>GP MDI 14.4 µg</title>
            <description>GP MDI 14.4 µg</description>
          </group>
        </group_list>
        <measure>
          <title>CL/F</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>L/h</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="657.91" lower_limit="479.15" upper_limit="973.62"/>
                    <measurement group_id="O2" value="449.10" lower_limit="421.97" upper_limit="476.24"/>
                    <measurement group_id="O3" value="785.60" lower_limit="681.20" upper_limit="890.00"/>
                    <measurement group_id="O4" value="423.12" lower_limit="415.74" upper_limit="427.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CL/F</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
        </group_list>
        <measure>
          <title>CL/F</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>L/h</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168.95" spread="45.28" lower_limit="76.15" upper_limit="232.63"/>
                    <measurement group_id="O2" value="161.55" spread="30.17" lower_limit="151.89" upper_limit="211.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vd/F</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 µg</title>
            <description>GP MDI 28.8 µg</description>
          </group>
          <group group_id="O4">
            <title>GP MDI 14.4 µg</title>
            <description>GP MDI 14.4 µg</description>
          </group>
        </group_list>
        <measure>
          <title>Vd/F</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>L</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3508.00" lower_limit="2089.69" upper_limit="4654.28"/>
                    <measurement group_id="O2" value="2577.78" lower_limit="2475.12" upper_limit="2680.44"/>
                    <measurement group_id="O3" value="3555.88" lower_limit="3509.62" upper_limit="3602.14"/>
                    <measurement group_id="O4" value="2101.03" lower_limit="1929.07" upper_limit="2193.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vd/F</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Vd/F</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>L</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1187.75" spread="313.20" lower_limit="516.40" upper_limit="1779.88"/>
                    <measurement group_id="O2" value="1054.16" spread="225.15" lower_limit="828.09" upper_limit="1618.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lambda z</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
          <group group_id="O4">
            <title>GP MDI 14.4 ug</title>
            <description>GP MDI 14.4 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Lambda z</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>1/h</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1506" spread="7.69" lower_limit="0.0183" upper_limit="0.2404"/>
                    <measurement group_id="O2" value="0.1983" spread="6.5" lower_limit="0.1007" upper_limit="0.5299"/>
                    <measurement group_id="O3" value="0.1100" spread="4.26" lower_limit="0.0067" upper_limit="0.3242"/>
                    <measurement group_id="O4" value="0.1614" lower_limit="0.0036" upper_limit="0.3333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Lambda z</title>
        <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment</description>
        <time_frame>Day 1</time_frame>
        <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Lambda z</title>
          <description>Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment</description>
          <population>Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)</population>
          <units>1/h</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1412" spread="0.0381" lower_limit="0.0483" upper_limit="0.2225"/>
                    <measurement group_id="O2" value="0.1470" spread="0.0410" lower_limit="0.0500" upper_limit="0.2140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
        <time_frame>12 Hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
          <population>Safety Population</population>
          <units>10^9cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Basophils (10^9cells/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.007" spread="0.025"/>
                    <measurement group_id="O2" value="0.000" spread="0.022"/>
                    <measurement group_id="O3" value="0.001" spread="0.028"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils (10^9cells/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.044" spread="0.048"/>
                    <measurement group_id="O2" value="0.033" spread="0.068"/>
                    <measurement group_id="O3" value="0.065" spread="0.103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Granulocytes (10^9cells/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.222" spread="1.436"/>
                    <measurement group_id="O2" value="0.483" spread="1.793"/>
                    <measurement group_id="O3" value="0.443" spread="1.278"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes (10^9cells/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.484" spread="1.710"/>
                    <measurement group_id="O2" value="0.780" spread="1.990"/>
                    <measurement group_id="O3" value="0.800" spread="1.526"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (10^9cells/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.147" spread="0.390"/>
                    <measurement group_id="O2" value="0.206" spread="0.402"/>
                    <measurement group_id="O3" value="0.235" spread="0.383"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes (10^9cells/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.065" spread="0.084"/>
                    <measurement group_id="O2" value="0.056" spread="0.115"/>
                    <measurement group_id="O3" value="0.055" spread="0.103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets (10^9cells/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.4" spread="24.5"/>
                    <measurement group_id="O2" value="-14.4" spread="16.2"/>
                    <measurement group_id="O3" value="-23.1" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
        <time_frame>12 Hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
          <population>Safety Population</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Basophils/leukocytes (ratio)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0001" spread="0.0044"/>
                    <measurement group_id="O2" value="-0.0013" spread="0.0040"/>
                    <measurement group_id="O3" value="-0.0013" spread="0.0039"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils/leukocytes (ratio)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0034" spread="0.0089"/>
                    <measurement group_id="O2" value="0.0026" spread="0.0131"/>
                    <measurement group_id="O3" value="0.0046" spread="0.0091"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Granulocytes/leukocytes (ratio)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0043" spread="0.0688"/>
                    <measurement group_id="O2" value="0.0003" spread="0.0818"/>
                    <measurement group_id="O3" value="-0.0010" spread="0.0759"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit (ratio)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.040" spread="0.022"/>
                    <measurement group_id="O2" value="-0.041" spread="0.030"/>
                    <measurement group_id="O3" value="-0.043" spread="0.023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/leukocytes (ratio)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0110" spread="0.0565"/>
                    <measurement group_id="O2" value="-0.0019" spread="0.0662"/>
                    <measurement group_id="O3" value="-0.0018" spread="0.0616"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes/leukocytes (ratio)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0034" spread="0.0125"/>
                    <measurement group_id="O2" value="0.0004" spread="0.0136"/>
                    <measurement group_id="O3" value="-0.0006" spread="0.0118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
        <time_frame>12 Hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
          <population>Safety Population</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ery. mean corpuscuar HGB (g/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" spread="15.5"/>
                    <measurement group_id="O2" value="8.5" spread="13.9"/>
                    <measurement group_id="O3" value="11.4" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin (g/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.81" spread="7.76"/>
                    <measurement group_id="O2" value="-10.61" spread="9.10"/>
                    <measurement group_id="O3" value="-10.38" spread="9.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)</description>
        <time_frame>12 Hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)</description>
          <population>Safety Population</population>
          <units>fL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.6"/>
                    <measurement group_id="O2" value="-0.8" spread="0.9"/>
                    <measurement group_id="O3" value="-0.9" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin)</description>
        <time_frame>12 Hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin)</description>
          <population>Safety Population</population>
          <units>pg/cell</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.78" spread="1.29"/>
                    <measurement group_id="O2" value="0.49" spread="1.08"/>
                    <measurement group_id="O3" value="0.75" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)</description>
        <time_frame>12 Hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)</description>
          <population>Safety Population</population>
          <units>10^12cells/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.391" spread="0.242"/>
                    <measurement group_id="O2" value="-0.419" spread="0.326"/>
                    <measurement group_id="O3" value="-0.433" spread="0.253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
          <population>Safety Population</population>
          <units>IU/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT (IU/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="4.3"/>
                    <measurement group_id="O2" value="-1.7" spread="3.1"/>
                    <measurement group_id="O3" value="-2.4" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline phosphatase (IU/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.2" spread="4.3"/>
                    <measurement group_id="O2" value="-5.0" spread="5.1"/>
                    <measurement group_id="O3" value="-6.0" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST (IU/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="3.7"/>
                    <measurement group_id="O2" value="-3.3" spread="2.6"/>
                    <measurement group_id="O3" value="-3.7" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gamma glutamyl transferase (IU/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="2.4"/>
                    <measurement group_id="O2" value="-1.6" spread="1.9"/>
                    <measurement group_id="O3" value="-2.2" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
          <population>Safety Population</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Albumin (g/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" spread="2.9"/>
                    <measurement group_id="O2" value="-6.9" spread="4.1"/>
                    <measurement group_id="O3" value="-6.7" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein (g/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.9" spread="5.3"/>
                    <measurement group_id="O2" value="-10.8" spread="6.7"/>
                    <measurement group_id="O3" value="-10.3" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
          <population>Safety Population</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blood urea nitrogen (mmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="1.45"/>
                    <measurement group_id="O2" value="0.34" spread="1.32"/>
                    <measurement group_id="O3" value="0.74" spread="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium (mmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="0.09"/>
                    <measurement group_id="O2" value="-0.14" spread="0.12"/>
                    <measurement group_id="O3" value="-0.13" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride (mmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="2.3"/>
                    <measurement group_id="O2" value="2.5" spread="1.8"/>
                    <measurement group_id="O3" value="2.3" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Magnesium (mmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="0.09"/>
                    <measurement group_id="O2" value="-0.07" spread="0.09"/>
                    <measurement group_id="O3" value="-0.04" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphorus (mmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.135" spread="0.165"/>
                    <measurement group_id="O2" value="0.163" spread="0.132"/>
                    <measurement group_id="O3" value="0.133" spread="0.164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium (mmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="2.1"/>
                    <measurement group_id="O2" value="0.5" spread="1.3"/>
                    <measurement group_id="O3" value="0.1" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose</description>
          <population>Safety Population</population>
          <units>μmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Creatinine (μmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.88" spread="11.14"/>
                    <measurement group_id="O2" value="4.92" spread="15.74"/>
                    <measurement group_id="O3" value="3.61" spread="13.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct bilirubin (μmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.06" spread="1.75"/>
                    <measurement group_id="O2" value="-2.53" spread="1.45"/>
                    <measurement group_id="O3" value="-2.64" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Iron (μmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.42524" spread="8.9"/>
                    <measurement group_id="O2" value="-2.81888" spread="7.07702"/>
                    <measurement group_id="O3" value="-2.58949" spread="8.19974"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total bilirubin (μmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.19" spread="5.68"/>
                    <measurement group_id="O2" value="-7.14" spread="4.80"/>
                    <measurement group_id="O3" value="-7.20" spread="5.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR)</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR)</description>
          <population>Safety Population</population>
          <units>mL/min/1.73m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="13.2"/>
                    <measurement group_id="O2" value="-7.2" spread="16.6"/>
                    <measurement group_id="O3" value="-3.5" spread="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)</description>
          <population>Safety Population</population>
          <units>μg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.169" spread="13.912"/>
                    <measurement group_id="O2" value="-11.949" spread="12.306"/>
                    <measurement group_id="O3" value="-11.669" spread="9.731"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose</title>
        <description>Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose</title>
          <description>Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose</description>
          <population>Safety Population</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Glucose (mmol/L) 30 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" lower_limit="-0.3" upper_limit="0.6"/>
                    <measurement group_id="O2" value="-0.08" lower_limit="-0.8" upper_limit="0.5"/>
                    <measurement group_id="O3" value="-0.01" lower_limit="-0.4" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose (mmol/L) 2 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" lower_limit="-0.3" upper_limit="0.4"/>
                    <measurement group_id="O2" value="-0.01" lower_limit="-0.7" upper_limit="0.8"/>
                    <measurement group_id="O3" value="-0.06" lower_limit="-0.4" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose (mmol/L) 4 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" lower_limit="-0.5" upper_limit="0.4"/>
                    <measurement group_id="O2" value="-0.24" lower_limit="-0.8" upper_limit="0.4"/>
                    <measurement group_id="O3" value="-0.16" lower_limit="-0.6" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose (mmol/L) 12 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" lower_limit="-0.4" upper_limit="0.7"/>
                    <measurement group_id="O2" value="0.18" lower_limit="-0.8" upper_limit="0.8"/>
                    <measurement group_id="O3" value="0.23" lower_limit="-0.3" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mmol/L) 30 minutes post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" lower_limit="-0.3" upper_limit="1.0"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-0.6" upper_limit="0.5"/>
                    <measurement group_id="O3" value="0.06" lower_limit="-0.5" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mmol/L) 2 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" lower_limit="-0.5" upper_limit="0.8"/>
                    <measurement group_id="O2" value="-0.07" lower_limit="-0.5" upper_limit="0.4"/>
                    <measurement group_id="O3" value="0.10" lower_limit="-0.4" upper_limit="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mmol/L) 4 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" lower_limit="-0.6" upper_limit="1.0"/>
                    <measurement group_id="O2" value="-0.12" lower_limit="-0.5" upper_limit="0.4"/>
                    <measurement group_id="O3" value="-0.07" lower_limit="-0.6" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mmol/L) 12 hours post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" lower_limit="-0.5" upper_limit="0.7"/>
                    <measurement group_id="O2" value="-0.06" lower_limit="-0.6" upper_limit="0.4"/>
                    <measurement group_id="O3" value="0.07" lower_limit="-0.5" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Heart Rate From Pre-dose to 12 Hours Post Dose</title>
        <description>Change in Heart Rate from Pre-dose to 12 hours Post dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Heart Rate From Pre-dose to 12 Hours Post Dose</title>
          <description>Change in Heart Rate from Pre-dose to 12 hours Post dose</description>
          <population>Safety Population</population>
          <units>Beats/Min</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" lower_limit="2" upper_limit="42"/>
                    <measurement group_id="O2" value="9.3" lower_limit="-4" upper_limit="36"/>
                    <measurement group_id="O3" value="4.5" lower_limit="-13" upper_limit="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in PR Interval From Pre-dose to 12 Hours Post Dose</title>
        <description>Change in PR Interval from Pre-dose to 12 hours Post dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PR Interval From Pre-dose to 12 Hours Post Dose</title>
          <description>Change in PR Interval from Pre-dose to 12 hours Post dose</description>
          <population>Safety Population</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.7" lower_limit="-22" upper_limit="6"/>
                    <measurement group_id="O2" value="-8.5" lower_limit="-46" upper_limit="14"/>
                    <measurement group_id="O3" value="-7.4" lower_limit="-36" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in QRS Axis From Pre-dose to 12 Hours Post Dose</title>
        <description>Change in QRS axis from Pre-dose to 12 hours Post dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in QRS Axis From Pre-dose to 12 Hours Post Dose</title>
          <description>Change in QRS axis from Pre-dose to 12 hours Post dose</description>
          <population>Safety Population</population>
          <units>QRS axis</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" lower_limit="-20" upper_limit="15"/>
                    <measurement group_id="O2" value="4.1" lower_limit="-11" upper_limit="76"/>
                    <measurement group_id="O3" value="0.0" lower_limit="-21" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in QRS Duration From Pre-dose to 12 Hours Post Dose</title>
        <description>Change in QRS duration from Pre-dose to 12 hours Post dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in QRS Duration From Pre-dose to 12 Hours Post Dose</title>
          <description>Change in QRS duration from Pre-dose to 12 hours Post dose</description>
          <population>Safety Population</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" lower_limit="-24" upper_limit="8"/>
                    <measurement group_id="O2" value="-1.1" lower_limit="-14" upper_limit="6"/>
                    <measurement group_id="O3" value="-4.0" lower_limit="-22" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in QT Interval From Pre-dose to 12 Hours Post Dose</title>
        <description>Change in QT Interval from Pre-dose to 12 hours Post dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in QT Interval From Pre-dose to 12 Hours Post Dose</title>
          <description>Change in QT Interval from Pre-dose to 12 hours Post dose</description>
          <population>Safety Population</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.5" lower_limit="-64" upper_limit="0"/>
                    <measurement group_id="O2" value="-24.8" lower_limit="-78" upper_limit="0"/>
                    <measurement group_id="O3" value="-20.5" lower_limit="-72" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose</title>
        <description>Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose</title>
          <description>Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose</description>
          <population>Safety Population</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" lower_limit="-14" upper_limit="40"/>
                    <measurement group_id="O2" value="4.4" lower_limit="-26" upper_limit="30"/>
                    <measurement group_id="O3" value="-5.8" lower_limit="-28" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose</title>
        <description>Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose</description>
        <time_frame>12 hours</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GFF MDI 28.8/9.6 ug</title>
            <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
          </group>
          <group group_id="O2">
            <title>GFF MDI 14.4/9.6 ug</title>
            <description>GFF MDI 14.4/9.6 ug</description>
          </group>
          <group group_id="O3">
            <title>GP MDI 28.8 ug</title>
            <description>GP MDI 28.8 ug</description>
          </group>
        </group_list>
        <measure>
          <title>Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose</title>
          <description>Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose</description>
          <population>Safety Population</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="23"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" lower_limit="-17" upper_limit="11"/>
                    <measurement group_id="O2" value="-5.4" lower_limit="-27" upper_limit="16"/>
                    <measurement group_id="O3" value="-10.8" lower_limit="-29" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.</time_frame>
      <desc>Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>GFF MDI 28.8/9.6 ug</title>
          <description>Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug</description>
        </group>
        <group group_id="E2">
          <title>GFF MDI 14.4/9.6 ug</title>
          <description>GFF MDI 14.4/9.6 ug</description>
        </group>
        <group group_id="E3">
          <title>GP MDI 28.8 ug</title>
          <description>GP MDI 28.8 ug</description>
        </group>
        <group group_id="E4">
          <title>GP MDI 14.4 µg</title>
          <description>GP MDI 14.4 µg</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA</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="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </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>Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Colin Reisner, MD, FCCP, FAAAAI</name_or_title>
      <organization>Pearl Therapeutics Inc.</organization>
      <phone>650-305-2600</phone>
      <email>creisner@pearltherapeutics.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/NCT02196714
org study id: PT003010-00
nct id: NCT02196714
lead sponsor: 
has dmc: No
A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over,
      Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the
      Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Cmax
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)
measure: Cmax
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)
measure: AUC 0-12
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)
measure: AUC 0-12
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)
measure: AUC 0-t
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)
measure: AUC 0-t
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)
measure: AUC 0-∞
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)
measure: AUC 0-∞
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)
measure: Tmax
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)
measure: Tmax
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)
measure: T 1/2
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)
measure: T 1/2
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)
measure: CL/F
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
measure: CL/F
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
measure: Vd/F
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment
measure: Vd/F
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
measure: Lambda z
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
measure: Lambda z
time frame: Day 1
description: Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
measure: Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
time frame: 12 Hours
description: Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose
measure: Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
time frame: 12 Hours
description: Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)
measure: Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
time frame: 12 Hours
description: Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin)
measure: Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
time frame: 12 Hours
description: Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)
measure: Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
time frame: 12 hours
description: Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose
measure: Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
time frame: 12 hours
description: Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR)
measure: Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
time frame: 12 hours
description: Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)
measure: Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
time frame: 12 hours
description: Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose
measure: Change in Heart Rate From Pre-dose to 12 Hours Post Dose
time frame: 12 hours
description: Change in Heart Rate from Pre-dose to 12 hours Post dose
measure: Change in PR Interval From Pre-dose to 12 Hours Post Dose
time frame: 12 hours
description: Change in PR Interval from Pre-dose to 12 hours Post dose
measure: Change in QRS Axis From Pre-dose to 12 Hours Post Dose
time frame: 12 hours
description: Change in QRS axis from Pre-dose to 12 hours Post dose
measure: Change in QRS Duration From Pre-dose to 12 Hours Post Dose
time frame: 12 hours
description: Change in QRS duration from Pre-dose to 12 hours Post dose
measure: Change in QT Interval From Pre-dose to 12 Hours Post Dose
time frame: 12 hours
description: Change in QT Interval from Pre-dose to 12 hours Post dose
measure: Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose
time frame: 12 hours
description: Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose
measure: Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose
time frame: 12 hours
description: Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose
arm group label: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1
arm group type: Experimental
description: Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)
arm group label: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2
arm group type: Experimental
description: Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
arm group label: Glycopyrronium (GP) Dose 1
arm group type: Experimental
description: Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
arm group label: Glycopyrronium (GP) Dose 2
arm group type: Experimental
description: Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)
intervention type: Drug
intervention name: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1
description: Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)
arm group label: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1
intervention type: Drug
intervention name: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2
description: Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
arm group label: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2
intervention type: Drug
intervention name: Glycopyrronium (GP) Dose 1
description: Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
arm group label: Glycopyrronium (GP) Dose 1
intervention type: Drug
intervention name: Glycopyrronium (GP) Dose 2
description: Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)
arm group label: Glycopyrronium (GP) Dose 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chadwick Orevillo
role: Study Chair
affiliation: Pearl Therapeutics, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glycopyrrolate
mesh term: Formoterol Fumarate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 