<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/NCT01727791</url>
  </required_header>
  <id_info>
    <org_study_id>A0081181</org_study_id>
    <secondary_id>2012-003197-57</secondary_id>
    <nct_id>NCT01727791</nct_id>
  </id_info>
  <brief_title>A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women</brief_title>
  <official_title>A Multiple Dose Pharmacokinetic Open-label Study Of Pregabalin (Lyrica Registered) In Healthy Lactating Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer's Upjohn has merged with Mylan to form Viatris Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in&#xD;
      healthy lactating women. The objectives are to determine whether pregabalin is secreted in&#xD;
      breast milk and if so, to characterize pregabalin pharmacokinetics in breast milk. Other&#xD;
      objectives are to estimate potential infant exposure to pregabalin if administered to&#xD;
      lactating women and to characterize the safety and tolerability of pregabalin in lactating&#xD;
      women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post approval commitment for the FDA&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)</measure>
    <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3</time_frame>
    <description>Area under the plasma concentration-time profile from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3</time_frame>
    <description>Cmax was the peak concentration in plasma post Day 3 dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3</time_frame>
    <description>Tmax was the time to peak concentration in plasma post Day 3 dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Half-Life (t1/2)</measure>
    <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3</time_frame>
    <description>Plasma decay half-life (t1/2) was the time for the plasma concentration to decrease by one-half. The t1/2 is based on the terminal elimination phase time points from this timeframe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Plasma Concentration During the Dosing Interval (Cav)</measure>
    <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3</time_frame>
    <description>Average plasma concentration during the dosing interval (Cav) was calculated by dividing AUCtau (plasma) with tau, where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minimum Observed Plasma Trough Concentration (Cmin)</measure>
    <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3</time_frame>
    <description>Cmin was the minimum observed plasma concentration of a drug after post Day 3 dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Oral Clearance (CL/F)</measure>
    <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3</time_frame>
    <description>Apparent oral clearance (CL/F) was calculated by dividing dose by the AUCtau, where tau was the dosing interval of 12 hours. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to End of Dosing Interval for Breast Milk (AUCtau [Breast Milk])</measure>
    <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
    <description>AUCtau (breast milk) was the area under the curve for breast milk, from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Concentration in Breast Milk (Cmax [Breast Milk])</measure>
    <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3</time_frame>
    <description>Cmax (breast milk) was the maximum observed concentration in breast milk post Day 3 dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Breast Milk Concentration (Tmax [Breast Milk])</measure>
    <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3</time_frame>
    <description>Tmax (breast milk) was time of the maximum observed breast milk concentration Day 3 post-dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal Half-Life for Breast Milk (t1/2 [Breast Milk])</measure>
    <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3</time_frame>
    <description>The terminal half-life for breast milk (t1/2 [breast milk]) was the time measured for breast milk concentration to decrease by one-half. For the first 5 participants enrolled under protocol amendment dated: 18 Sep 2012, breast milk was collected up to 24 hours after Day 3 dosing over the following time intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 hours. Terminal half-life was determined over those points characterizing the elimination phase. For the remaining 5 participants, there were 3 additional collection intervals (24 to 32, 32 to 40, 40 to 48 hours) for characterizing the terminal elimination phase. The t1/2 (breast milk) is based on the terminal elimination phase time points from this timeframe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Breast Milk Concentration During the Dosing Interval (Cav)</measure>
    <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
    <description>Average breast milk concentration during the dosing interval (Cav) was calculated by dividing AUCtau (breast milk) with tau, where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount Excreted in Breast Milk Over the Dosing Interval Tau (Aetaubm)</measure>
    <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
    <description>Aetaubm was the amount excreted in breast milk over the dosing interval tau (12 hours). It was calculated as the sum of (breast milk concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Sample volume was based on ratio of volume weight and density.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Dose Excreted in Breast Milk During the Dosing Interval Tau (Aetaubm Percent)</measure>
    <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
    <description>Percentage of dose excreted in breast milk during the dosing interval tau (Aetaubm percent) was calculated by using the formula: 100*(Aetaubm [sum of {breast milk concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by dose), where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breast Milk Clearance (CLbm)</measure>
    <time_frame>Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
    <description>Breast milk clearance (CLbm) was calculated by dividing Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) by plasma AUCtau, where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount Recovered in Urine During the Dosing Interval Tau (Aetauurine)</measure>
    <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
    <description>Aetauurine was the amount excreted in urine over the dosing interval tau (12 hours). It was calculated as the sum of (urine concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Here, sample volume was based on the ratio of volume weight and density.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of Dose Recovered in Urine During the Dosing Interval Tau (Aetauurine Percent)</measure>
    <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
    <description>Percent of dose recovered in urine during the dosing interval tau (Aetauurine percent) was calculated as 100* (Aetau [sum of {urine concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by the dose), where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal Clearance (CLr)</measure>
    <time_frame>Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Urine: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8 and 8 to 12 hours post-dose on Day 3</time_frame>
    <description>Renal clearance (CLr) was the volume of plasma from which the drug was completely removed by the kidney in a given amount of time. It was calculated by dividing Aetauurine (sum of [urine concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) with the plasma AUCtau, where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily Amount of Pregabalin Excreted in Breast Milk (Ae24bm)</measure>
    <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
    <description>Ae24bm was the daily amount of pregabalin excreted in breast milk. It was calculated by the formula: 2 * Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose), where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Milk to Plasma Ratio for AUCtau (MPAUCtau)</measure>
    <time_frame>Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
    <description>MPAUCtau was the ratio of AUCtau (breast milk) to AUCtau (plasma), where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Milk to Plasma Ratio for Maximum Observed Concentration (MPCmax)</measure>
    <time_frame>Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3</time_frame>
    <description>Milk to plasma ratio for maximum observed concentration (MPCmax) was calculated as the ratio of Cmax (breast milk) to Cmax (plasma).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight Normalized Infant Dose (BWNID)</measure>
    <time_frame>Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
    <description>Body weight normalized infant dose (BWNID) of pregabalin was the dose that an infant received from breast-feeding and was calculated from the milk to plasma AUCtau ratio multiplied by the average maternal plasma pregabalin concentration (Cav) multiplied by the standardized milk consumption for an infant (150 milliliter/kilogram/day [mL/kg/day]), where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Weight Normalized Maternal Dose (BWNMD)</measure>
    <time_frame>Pre-dose to 24 hours post-dose on Day 3</time_frame>
    <description>Body weight normalized maternal dose (BWNMD) was calculated as the maternal dose in microgram per day (mcg/day) divided by maternal weight in kilogram (kg) at screening.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant Dose Expressed as Percentage of Body Weight Normalized Maternal Dose (BWNIDPCM)</measure>
    <time_frame>Pre-dose to 24 hours post-dose on Day 3</time_frame>
    <description>Infant dose expressed as percentage of body weight normalized maternal dose (BWNIDPCM) was the relative infant dose (relative to maternal dose) calculated by the formula: 100 * BWNID (Body Weight Normalized Infant Dose) / Body Weight Normalized Maternal Dose (BWNMD), where tau was the dosing interval of 12 hours.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to 28 days after last dose of study drug</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Laboratory Abnormalities</measure>
    <time_frame>Baseline up to 28 days after last dose of study drug</time_frame>
    <description>The following parameters were analyzed for laboratory abnormalities: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelets, white blood cell count, lymphocytes, total neutrophils, basophils, eosinophils, monocytes); liver function (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (urine pH, glucose, ketones, protein, urine blood/hemoglobin, nitrite).</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Vital Signs</measure>
    <time_frame>Baseline up to 28 days after last dose of study drug</time_frame>
    <description>The following parameters were analyzed for examination of vital signs: electrocardiogram (ECG), systolic and diastolic blood pressure, temperature, pulse rate, respiratory rate, radial pulse and body temperature.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy Lactating Women</condition>
  <arm_group>
    <arm_group_label>open label</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pregabalin (Lyrica)</intervention_name>
    <description>Subjects will receive a single 150 mg dose of pregabalin in the evening of Day 1, a 150 mg dose of pregabalin in the morning and evening of Day 2 and a 150 mg dose in the morning of Day 3.</description>
    <arm_group_label>open label</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy lactating females between the ages of 18 and 45 years (inclusive) who are&#xD;
             actively breast-feeding or expressing breast milk and are at least 12 weeks post&#xD;
             partum.&#xD;
&#xD;
          -  Subjects must be willing to temporarily discontinue breast feeding their infants&#xD;
             before the Day 1 evening dose through to 42 hours after the last dose&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of significant adverse reaction to pregabalin or gabapentin.&#xD;
&#xD;
          -  Subjects pregnant or unwilling or unable to comply with the Lifestyle guidelines&#xD;
             presented in the protocol during the study period and through the follow-up visit.&#xD;
&#xD;
          -  Subjects with evidence or history of clinically significant hematological, renal,&#xD;
             endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric&#xD;
             (including post natal depression), neurologic or allergic disease (including drug&#xD;
             allergies, but excluding untreated asymptomatic, seasonal allergies at time of&#xD;
             dosing).&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pfizer Clinical Research Unit</name>
      <address>
        <city>Brussels</city>
        <zip>B-1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081181&amp;StudyName=A%20Study%20Of%20Pregabalin%20%28Lyrica%29%20Drug%20Levels%20In%20Urine%2C%20Plasma%20And%20Breast%20Milk%20Of%20Healthy%20Lactating%20Women</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <results_first_submitted>April 11, 2016</results_first_submitted>
  <results_first_submitted_qc>April 11, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 18, 2016</results_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pharmacokinetic</keyword>
  <keyword>pregabalin</keyword>
  <keyword>lactation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Eligible participants were healthy, lactating females between the ages of 18 and 45 years (inclusive) who were actively breastfeeding or expressing breast milk, who were at least 12 weeks post-partum and not currently pregnant.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Pregabalin</title>
          <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis population included participants who received at least 1 dose of study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Pregabalin</title>
          <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </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="31.7" spread="4.5"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)</title>
        <description>Area under the plasma concentration-time profile from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.</description>
        <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3</time_frame>
        <population>The pharmacokinetic (PK) parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)</title>
          <description>Area under the plasma concentration-time profile from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.</description>
          <population>The pharmacokinetic (PK) parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>microgram*hour/milliliter (mcg*hr/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.50" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax)</title>
        <description>Cmax was the peak concentration in plasma post Day 3 dose.</description>
        <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax)</title>
          <description>Cmax was the peak concentration in plasma post Day 3 dose.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.67" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Reach Maximum Observed Plasma Concentration (Tmax)</title>
        <description>Tmax was the time to peak concentration in plasma post Day 3 dose.</description>
        <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Plasma Concentration (Tmax)</title>
          <description>Tmax was the time to peak concentration in plasma post Day 3 dose.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>hr</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.01" lower_limit="1.00" upper_limit="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Half-Life (t1/2)</title>
        <description>Plasma decay half-life (t1/2) was the time for the plasma concentration to decrease by one-half. The t1/2 is based on the terminal elimination phase time points from this timeframe.</description>
        <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Half-Life (t1/2)</title>
          <description>Plasma decay half-life (t1/2) was the time for the plasma concentration to decrease by one-half. The t1/2 is based on the terminal elimination phase time points from this timeframe.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.624" spread="0.65656"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Plasma Concentration During the Dosing Interval (Cav)</title>
        <description>Average plasma concentration during the dosing interval (Cav) was calculated by dividing AUCtau (plasma) with tau, where tau was the dosing interval of 12 hours.</description>
        <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Plasma Concentration During the Dosing Interval (Cav)</title>
          <description>Average plasma concentration during the dosing interval (Cav) was calculated by dividing AUCtau (plasma) with tau, where tau was the dosing interval of 12 hours.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.709" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Minimum Observed Plasma Trough Concentration (Cmin)</title>
        <description>Cmin was the minimum observed plasma concentration of a drug after post Day 3 dose.</description>
        <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Observed Plasma Trough Concentration (Cmin)</title>
          <description>Cmin was the minimum observed plasma concentration of a drug after post Day 3 dose.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.246" spread="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Oral Clearance (CL/F)</title>
        <description>Apparent oral clearance (CL/F) was calculated by dividing dose by the AUCtau, where tau was the dosing interval of 12 hours. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
        <time_frame>Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Oral Clearance (CL/F)</title>
          <description>Apparent oral clearance (CL/F) was calculated by dividing dose by the AUCtau, where tau was the dosing interval of 12 hours. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mL/minute</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.90" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve From Time Zero to End of Dosing Interval for Breast Milk (AUCtau [Breast Milk])</title>
        <description>AUCtau (breast milk) was the area under the curve for breast milk, from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.</description>
        <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve From Time Zero to End of Dosing Interval for Breast Milk (AUCtau [Breast Milk])</title>
          <description>AUCtau (breast milk) was the area under the curve for breast milk, from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mcg*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.64" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Concentration in Breast Milk (Cmax [Breast Milk])</title>
        <description>Cmax (breast milk) was the maximum observed concentration in breast milk post Day 3 dose.</description>
        <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration in Breast Milk (Cmax [Breast Milk])</title>
          <description>Cmax (breast milk) was the maximum observed concentration in breast milk post Day 3 dose.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mcg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.474" spread="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Reach Maximum Observed Breast Milk Concentration (Tmax [Breast Milk])</title>
        <description>Tmax (breast milk) was time of the maximum observed breast milk concentration Day 3 post-dose.</description>
        <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Breast Milk Concentration (Tmax [Breast Milk])</title>
          <description>Tmax (breast milk) was time of the maximum observed breast milk concentration Day 3 post-dose.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>hr</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.63" lower_limit="3.08" upper_limit="6.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Terminal Half-Life for Breast Milk (t1/2 [Breast Milk])</title>
        <description>The terminal half-life for breast milk (t1/2 [breast milk]) was the time measured for breast milk concentration to decrease by one-half. For the first 5 participants enrolled under protocol amendment dated: 18 Sep 2012, breast milk was collected up to 24 hours after Day 3 dosing over the following time intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 hours. Terminal half-life was determined over those points characterizing the elimination phase. For the remaining 5 participants, there were 3 additional collection intervals (24 to 32, 32 to 40, 40 to 48 hours) for characterizing the terminal elimination phase. The t1/2 (breast milk) is based on the terminal elimination phase time points from this timeframe.</description>
        <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Half-Life for Breast Milk (t1/2 [Breast Milk])</title>
          <description>The terminal half-life for breast milk (t1/2 [breast milk]) was the time measured for breast milk concentration to decrease by one-half. For the first 5 participants enrolled under protocol amendment dated: 18 Sep 2012, breast milk was collected up to 24 hours after Day 3 dosing over the following time intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 hours. Terminal half-life was determined over those points characterizing the elimination phase. For the remaining 5 participants, there were 3 additional collection intervals (24 to 32, 32 to 40, 40 to 48 hours) for characterizing the terminal elimination phase. The t1/2 (breast milk) is based on the terminal elimination phase time points from this timeframe.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.117" spread="3.0871"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Breast Milk Concentration During the Dosing Interval (Cav)</title>
        <description>Average breast milk concentration during the dosing interval (Cav) was calculated by dividing AUCtau (breast milk) with tau, where tau was the dosing interval of 12 hours.</description>
        <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Breast Milk Concentration During the Dosing Interval (Cav)</title>
          <description>Average breast milk concentration during the dosing interval (Cav) was calculated by dividing AUCtau (breast milk) with tau, where tau was the dosing interval of 12 hours.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mcg/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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.116" spread="27" lower_limit="1.34" upper_limit="3.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Amount Excreted in Breast Milk Over the Dosing Interval Tau (Aetaubm)</title>
        <description>Aetaubm was the amount excreted in breast milk over the dosing interval tau (12 hours). It was calculated as the sum of (breast milk concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Sample volume was based on ratio of volume weight and density.</description>
        <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Amount Excreted in Breast Milk Over the Dosing Interval Tau (Aetaubm)</title>
          <description>Aetaubm was the amount excreted in breast milk over the dosing interval tau (12 hours). It was calculated as the sum of (breast milk concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Sample volume was based on ratio of volume weight and density.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mcg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="286.9" spread="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Dose Excreted in Breast Milk During the Dosing Interval Tau (Aetaubm Percent)</title>
        <description>Percentage of dose excreted in breast milk during the dosing interval tau (Aetaubm percent) was calculated by using the formula: 100*(Aetaubm [sum of {breast milk concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by dose), where tau was the dosing interval of 12 hours.</description>
        <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dose Excreted in Breast Milk During the Dosing Interval Tau (Aetaubm Percent)</title>
          <description>Percentage of dose excreted in breast milk during the dosing interval tau (Aetaubm percent) was calculated by using the formula: 100*(Aetaubm [sum of {breast milk concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by dose), where tau was the dosing interval of 12 hours.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>percentage of dose</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1913" spread="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Breast Milk Clearance (CLbm)</title>
        <description>Breast milk clearance (CLbm) was calculated by dividing Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) by plasma AUCtau, where tau was the dosing interval of 12 hours.</description>
        <time_frame>Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Breast Milk Clearance (CLbm)</title>
          <description>Breast milk clearance (CLbm) was calculated by dividing Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) by plasma AUCtau, where tau was the dosing interval of 12 hours.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mL/min</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1473" spread="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Amount Recovered in Urine During the Dosing Interval Tau (Aetauurine)</title>
        <description>Aetauurine was the amount excreted in urine over the dosing interval tau (12 hours). It was calculated as the sum of (urine concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Here, sample volume was based on the ratio of volume weight and density.</description>
        <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Amount Recovered in Urine During the Dosing Interval Tau (Aetauurine)</title>
          <description>Aetauurine was the amount excreted in urine over the dosing interval tau (12 hours). It was calculated as the sum of (urine concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Here, sample volume was based on the ratio of volume weight and density.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133.1" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent of Dose Recovered in Urine During the Dosing Interval Tau (Aetauurine Percent)</title>
        <description>Percent of dose recovered in urine during the dosing interval tau (Aetauurine percent) was calculated as 100* (Aetau [sum of {urine concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by the dose), where tau was the dosing interval of 12 hours.</description>
        <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Dose Recovered in Urine During the Dosing Interval Tau (Aetauurine Percent)</title>
          <description>Percent of dose recovered in urine during the dosing interval tau (Aetauurine percent) was calculated as 100* (Aetau [sum of {urine concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by the dose), where tau was the dosing interval of 12 hours.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>percentage of dose</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.6" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Renal Clearance (CLr)</title>
        <description>Renal clearance (CLr) was the volume of plasma from which the drug was completely removed by the kidney in a given amount of time. It was calculated by dividing Aetauurine (sum of [urine concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) with the plasma AUCtau, where tau was the dosing interval of 12 hours.</description>
        <time_frame>Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Urine: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8 and 8 to 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Clearance (CLr)</title>
          <description>Renal clearance (CLr) was the volume of plasma from which the drug was completely removed by the kidney in a given amount of time. It was calculated by dividing Aetauurine (sum of [urine concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) with the plasma AUCtau, where tau was the dosing interval of 12 hours.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mL/min</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.16" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Daily Amount of Pregabalin Excreted in Breast Milk (Ae24bm)</title>
        <description>Ae24bm was the daily amount of pregabalin excreted in breast milk. It was calculated by the formula: 2 * Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose), where tau was the dosing interval of 12 hours.</description>
        <time_frame>Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Daily Amount of Pregabalin Excreted in Breast Milk (Ae24bm)</title>
          <description>Ae24bm was the daily amount of pregabalin excreted in breast milk. It was calculated by the formula: 2 * Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose), where tau was the dosing interval of 12 hours.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mcg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="664.6" spread="60" lower_limit="270" upper_limit="1720"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Milk to Plasma Ratio for AUCtau (MPAUCtau)</title>
        <description>MPAUCtau was the ratio of AUCtau (breast milk) to AUCtau (plasma), where tau was the dosing interval of 12 hours.</description>
        <time_frame>Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Milk to Plasma Ratio for AUCtau (MPAUCtau)</title>
          <description>MPAUCtau was the ratio of AUCtau (breast milk) to AUCtau (plasma), where tau was the dosing interval of 12 hours.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.769" lower_limit="0.493" upper_limit="0.956"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Milk to Plasma Ratio for Maximum Observed Concentration (MPCmax)</title>
        <description>Milk to plasma ratio for maximum observed concentration (MPCmax) was calculated as the ratio of Cmax (breast milk) to Cmax (plasma).</description>
        <time_frame>Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Milk to Plasma Ratio for Maximum Observed Concentration (MPCmax)</title>
          <description>Milk to plasma ratio for maximum observed concentration (MPCmax) was calculated as the ratio of Cmax (breast milk) to Cmax (plasma).</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5413" lower_limit="0.335" upper_limit="0.755"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight Normalized Infant Dose (BWNID)</title>
        <description>Body weight normalized infant dose (BWNID) of pregabalin was the dose that an infant received from breast-feeding and was calculated from the milk to plasma AUCtau ratio multiplied by the average maternal plasma pregabalin concentration (Cav) multiplied by the standardized milk consumption for an infant (150 milliliter/kilogram/day [mL/kg/day]), where tau was the dosing interval of 12 hours.</description>
        <time_frame>Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight Normalized Infant Dose (BWNID)</title>
          <description>Body weight normalized infant dose (BWNID) of pregabalin was the dose that an infant received from breast-feeding and was calculated from the milk to plasma AUCtau ratio multiplied by the average maternal plasma pregabalin concentration (Cav) multiplied by the standardized milk consumption for an infant (150 milliliter/kilogram/day [mL/kg/day]), where tau was the dosing interval of 12 hours.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mcg/kg/day</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="317.3" spread="27" lower_limit="202" upper_limit="458"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Body Weight Normalized Maternal Dose (BWNMD)</title>
        <description>Body weight normalized maternal dose (BWNMD) was calculated as the maternal dose in microgram per day (mcg/day) divided by maternal weight in kilogram (kg) at screening.</description>
        <time_frame>Pre-dose to 24 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight Normalized Maternal Dose (BWNMD)</title>
          <description>Body weight normalized maternal dose (BWNMD) was calculated as the maternal dose in microgram per day (mcg/day) divided by maternal weight in kilogram (kg) at screening.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>mcg/kg/day</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4343.6" spread="27" lower_limit="3444" upper_limit="5676"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Infant Dose Expressed as Percentage of Body Weight Normalized Maternal Dose (BWNIDPCM)</title>
        <description>Infant dose expressed as percentage of body weight normalized maternal dose (BWNIDPCM) was the relative infant dose (relative to maternal dose) calculated by the formula: 100 * BWNID (Body Weight Normalized Infant Dose) / Body Weight Normalized Maternal Dose (BWNMD), where tau was the dosing interval of 12 hours.</description>
        <time_frame>Pre-dose to 24 hours post-dose on Day 3</time_frame>
        <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Infant Dose Expressed as Percentage of Body Weight Normalized Maternal Dose (BWNIDPCM)</title>
          <description>Infant dose expressed as percentage of body weight normalized maternal dose (BWNIDPCM) was the relative infant dose (relative to maternal dose) calculated by the formula: 100 * BWNID (Body Weight Normalized Infant Dose) / Body Weight Normalized Maternal Dose (BWNMD), where tau was the dosing interval of 12 hours.</description>
          <population>The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.</population>
          <units>percentage of dose</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.341" spread="27" lower_limit="4.43" upper_limit="9.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.</description>
        <time_frame>Baseline up to 28 days after last dose of study drug</time_frame>
        <population>The safety analysis population included participants who received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.</description>
          <population>The safety analysis population included participants who received at least 1 dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of Participants with AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Participants with SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Laboratory Abnormalities</title>
        <description>The following parameters were analyzed for laboratory abnormalities: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelets, white blood cell count, lymphocytes, total neutrophils, basophils, eosinophils, monocytes); liver function (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (urine pH, glucose, ketones, protein, urine blood/hemoglobin, nitrite).</description>
        <time_frame>Baseline up to 28 days after last dose of study drug</time_frame>
        <population>The safety analysis population included participants who received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities</title>
          <description>The following parameters were analyzed for laboratory abnormalities: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelets, white blood cell count, lymphocytes, total neutrophils, basophils, eosinophils, monocytes); liver function (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (urine pH, glucose, ketones, protein, urine blood/hemoglobin, nitrite).</description>
          <population>The safety analysis population included participants who received at least 1 dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in Vital Signs</title>
        <description>The following parameters were analyzed for examination of vital signs: electrocardiogram (ECG), systolic and diastolic blood pressure, temperature, pulse rate, respiratory rate, radial pulse and body temperature.</description>
        <time_frame>Baseline up to 28 days after last dose of study drug</time_frame>
        <population>The safety analysis population included participants who received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in Vital Signs</title>
          <description>The following parameters were analyzed for examination of vital signs: electrocardiogram (ECG), systolic and diastolic blood pressure, temperature, pulse rate, respiratory rate, radial pulse and body temperature.</description>
          <population>The safety analysis population included participants who received at least 1 dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 28 days after last dose of study drug</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pregabalin</title>
          <description>Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT01727791
org study id: A0081181
secondary id: 2012-003197-57
nct id: NCT01727791
lead sponsor: 
has dmc: No
This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in
      healthy lactating women. The objectives are to determine whether pregabalin is secreted in
      breast milk and if so, to characterize pregabalin pharmacokinetics in breast milk. Other
      objectives are to estimate potential infant exposure to pregabalin if administered to
      lactating women and to characterize the safety and tolerability of pregabalin in lactating
      women.
Post approval commitment for the FDA
allocation: Non-Randomized
primary purpose: Other
masking: None (Open Label)
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
time frame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3
description: Area under the plasma concentration-time profile from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
description: Cmax was the peak concentration in plasma post Day 3 dose.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
description: Tmax was the time to peak concentration in plasma post Day 3 dose.
measure: Plasma Half-Life (t1/2)
time frame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
description: Plasma decay half-life (t1/2) was the time for the plasma concentration to decrease by one-half. The t1/2 is based on the terminal elimination phase time points from this timeframe.
measure: Average Plasma Concentration During the Dosing Interval (Cav)
time frame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3
description: Average plasma concentration during the dosing interval (Cav) was calculated by dividing AUCtau (plasma) with tau, where tau was the dosing interval of 12 hours.
measure: Minimum Observed Plasma Trough Concentration (Cmin)
time frame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
description: Cmin was the minimum observed plasma concentration of a drug after post Day 3 dose.
measure: Apparent Oral Clearance (CL/F)
time frame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3
description: Apparent oral clearance (CL/F) was calculated by dividing dose by the AUCtau, where tau was the dosing interval of 12 hours. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
measure: Area Under the Curve From Time Zero to End of Dosing Interval for Breast Milk (AUCtau [Breast Milk])
time frame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
description: AUCtau (breast milk) was the area under the curve for breast milk, from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.
measure: Maximum Observed Concentration in Breast Milk (Cmax [Breast Milk])
time frame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
description: Cmax (breast milk) was the maximum observed concentration in breast milk post Day 3 dose.
measure: Time to Reach Maximum Observed Breast Milk Concentration (Tmax [Breast Milk])
time frame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
description: Tmax (breast milk) was time of the maximum observed breast milk concentration Day 3 post-dose.
measure: Terminal Half-Life for Breast Milk (t1/2 [Breast Milk])
time frame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
description: The terminal half-life for breast milk (t1/2 [breast milk]) was the time measured for breast milk concentration to decrease by one-half. For the first 5 participants enrolled under protocol amendment dated: 18 Sep 2012, breast milk was collected up to 24 hours after Day 3 dosing over the following time intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 hours. Terminal half-life was determined over those points characterizing the elimination phase. For the remaining 5 participants, there were 3 additional collection intervals (24 to 32, 32 to 40, 40 to 48 hours) for characterizing the terminal elimination phase. The t1/2 (breast milk) is based on the terminal elimination phase time points from this timeframe.
measure: Average Breast Milk Concentration During the Dosing Interval (Cav)
time frame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
description: Average breast milk concentration during the dosing interval (Cav) was calculated by dividing AUCtau (breast milk) with tau, where tau was the dosing interval of 12 hours.
measure: Amount Excreted in Breast Milk Over the Dosing Interval Tau (Aetaubm)
time frame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
description: Aetaubm was the amount excreted in breast milk over the dosing interval tau (12 hours). It was calculated as the sum of (breast milk concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Sample volume was based on ratio of volume weight and density.
measure: Percentage of Dose Excreted in Breast Milk During the Dosing Interval Tau (Aetaubm Percent)
time frame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
description: Percentage of dose excreted in breast milk during the dosing interval tau (Aetaubm percent) was calculated by using the formula: 100*(Aetaubm [sum of {breast milk concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by dose), where tau was the dosing interval of 12 hours.
measure: Breast Milk Clearance (CLbm)
time frame: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
description: Breast milk clearance (CLbm) was calculated by dividing Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) by plasma AUCtau, where tau was the dosing interval of 12 hours.
measure: Amount Recovered in Urine During the Dosing Interval Tau (Aetauurine)
time frame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
description: Aetauurine was the amount excreted in urine over the dosing interval tau (12 hours). It was calculated as the sum of (urine concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Here, sample volume was based on the ratio of volume weight and density.
measure: Percent of Dose Recovered in Urine During the Dosing Interval Tau (Aetauurine Percent)
time frame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
description: Percent of dose recovered in urine during the dosing interval tau (Aetauurine percent) was calculated as 100* (Aetau [sum of {urine concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by the dose), where tau was the dosing interval of 12 hours.
measure: Renal Clearance (CLr)
time frame: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Urine: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8 and 8 to 12 hours post-dose on Day 3
description: Renal clearance (CLr) was the volume of plasma from which the drug was completely removed by the kidney in a given amount of time. It was calculated by dividing Aetauurine (sum of [urine concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) with the plasma AUCtau, where tau was the dosing interval of 12 hours.
measure: Daily Amount of Pregabalin Excreted in Breast Milk (Ae24bm)
time frame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
description: Ae24bm was the daily amount of pregabalin excreted in breast milk. It was calculated by the formula: 2 * Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose), where tau was the dosing interval of 12 hours.
measure: Milk to Plasma Ratio for AUCtau (MPAUCtau)
time frame: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
description: MPAUCtau was the ratio of AUCtau (breast milk) to AUCtau (plasma), where tau was the dosing interval of 12 hours.
measure: Milk to Plasma Ratio for Maximum Observed Concentration (MPCmax)
time frame: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
description: Milk to plasma ratio for maximum observed concentration (MPCmax) was calculated as the ratio of Cmax (breast milk) to Cmax (plasma).
measure: Body Weight Normalized Infant Dose (BWNID)
time frame: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
description: Body weight normalized infant dose (BWNID) of pregabalin was the dose that an infant received from breast-feeding and was calculated from the milk to plasma AUCtau ratio multiplied by the average maternal plasma pregabalin concentration (Cav) multiplied by the standardized milk consumption for an infant (150 milliliter/kilogram/day [mL/kg/day]), where tau was the dosing interval of 12 hours.
measure: Body Weight Normalized Maternal Dose (BWNMD)
time frame: Pre-dose to 24 hours post-dose on Day 3
description: Body weight normalized maternal dose (BWNMD) was calculated as the maternal dose in microgram per day (mcg/day) divided by maternal weight in kilogram (kg) at screening.
measure: Infant Dose Expressed as Percentage of Body Weight Normalized Maternal Dose (BWNIDPCM)
time frame: Pre-dose to 24 hours post-dose on Day 3
description: Infant dose expressed as percentage of body weight normalized maternal dose (BWNIDPCM) was the relative infant dose (relative to maternal dose) calculated by the formula: 100 * BWNID (Body Weight Normalized Infant Dose) / Body Weight Normalized Maternal Dose (BWNMD), where tau was the dosing interval of 12 hours.
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
time frame: Baseline up to 28 days after last dose of study drug
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
measure: Number of Participants With Laboratory Abnormalities
time frame: Baseline up to 28 days after last dose of study drug
description: The following parameters were analyzed for laboratory abnormalities: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelets, white blood cell count, lymphocytes, total neutrophils, basophils, eosinophils, monocytes); liver function (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (urine pH, glucose, ketones, protein, urine blood/hemoglobin, nitrite).
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
time frame: Baseline up to 28 days after last dose of study drug
description: The following parameters were analyzed for examination of vital signs: electrocardiogram (ECG), systolic and diastolic blood pressure, temperature, pulse rate, respiratory rate, radial pulse and body temperature.
arm group label: open label
arm group type: Experimental
intervention type: Drug
intervention name: pregabalin (Lyrica)
description: Subjects will receive a single 150 mg dose of pregabalin in the evening of Day 1, a 150 mg dose of pregabalin in the morning and evening of Day 2 and a 150 mg dose in the morning of Day 3.
arm group label: open label
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: Belgium
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081181&StudyName=A%20Study%20Of%20Pregabalin%20%28Lyrica%29%20Drug%20Levels%20In%20Urine%2C%20Plasma%20And%20Breast%20Milk%20Of%20Healthy%20Lactating%20Women
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Pregabalin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 