<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/NCT02264132</url>
  </required_header>
  <id_info>
    <org_study_id>248.607</org_study_id>
    <nct_id>NCT02264132</nct_id>
  </id_info>
  <brief_title>Increasing Dose Study of Pramipexole in Two-way Cross-over Comparison of ER Tablet Versus IR Tablet in Japanese Healthy Male Volunteers</brief_title>
  <official_title>A Multiple Dose Study of Pramipexole With Increasing Doses (0.375 mg to 1.5 mg q.d.) of Oral Extended Release (ER) Tablet in Two-way Cross-over Comparison of 0.375 mg ER Tablet q.d. Versus 0.125 mg Immediate Release (IR) Tablet t.i.d. and 1.5 mg ER Tablet q.d. Versus 0.5 mg IR Tablet t.i.d. in Japanese Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objectives of this study were to investigate relative BA at steady state and to&#xD;
      investigate dose proportionality of pharmacokinetic parameters&#xD;
&#xD;
      Relative BA at steady state:&#xD;
&#xD;
        -  Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d.&#xD;
&#xD;
        -  Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d.&#xD;
&#xD;
      Dose proportionality of pharmacokinetic parameters:&#xD;
&#xD;
      · Pramipexole ER dosages from 0.375 to 1.5 mg q.d.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2006</start_date>
  <primary_completion_date type="Actual">November 2006</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)</measure>
    <time_frame>up to day 5</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
    <description>Relative BA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
    <description>Dose proportionality (only for ER)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)</measure>
    <time_frame>up to day 5</time_frame>
    <description>Dose proportionality (only for ER)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
    <description>Dose proportionality (only for ER)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)</measure>
    <time_frame>up to day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin,ss (minimum measured concentration of the analyte in plasma at steady state)</measure>
    <time_frame>up to day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTF (peak-trough fluctuation)</measure>
    <time_frame>up to day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state)</measure>
    <time_frame>up to day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)</measure>
    <time_frame>up to day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cavg (average concentration of the analyte in plasma at steady state)</measure>
    <time_frame>up to day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2,ss (terminal half-life of the analyte in plasma at steady state)</measure>
    <time_frame>up to day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F,ss (apparent clearance of the analyte in plasma at steady state after</measure>
    <time_frame>up to day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ)</measure>
    <time_frame>up to day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following oral administration)</measure>
    <time_frame>up to day 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)</measure>
    <time_frame>up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ae0-8,ss for IR (amount of analyte that is eliminated in urine from 0 to 8 hours at steady state)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-8,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 8 hours at steady state)</measure>
    <time_frame>up to 8 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 7 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>Day 5</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Pramipexole ER tablet versus Pramipexole IR tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pramipexole IR tablet versus Pramipexole ER tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole ER tablet</intervention_name>
    <arm_group_label>Pramipexole ER tablet versus Pramipexole IR tablet</arm_group_label>
    <arm_group_label>Pramipexole IR tablet versus Pramipexole ER tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole IR tablet</intervention_name>
    <arm_group_label>Pramipexole ER tablet versus Pramipexole IR tablet</arm_group_label>
    <arm_group_label>Pramipexole IR tablet versus Pramipexole ER tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects participating in the study are healthy male volunteers&#xD;
&#xD;
          -  Age between 20 and 40 years&#xD;
&#xD;
          -  Body mass index (BMI) between 17.6 and 26.4 kg/m2&#xD;
&#xD;
          -  All volunteers must give written informed consent before screening to participate in&#xD;
             this study and before first drug administration on Day 1 at Visit 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any findings of the medical examination (including blood pressure, pulse rate, ECG,&#xD;
             and laboratory test parameters) of clinical relevance&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy), psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or acute infections&#xD;
&#xD;
          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant&#xD;
             to the trial as judged by the investigator&#xD;
&#xD;
          -  Intake of drugs with a long half-life (&gt;24 hours) within at least one month or less&#xD;
             than ten half-lives of the respective drug before the administration of&#xD;
             investigational products&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial within 7 days before&#xD;
             the start of drug administration in the study or during the study period&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (within 4 months before&#xD;
             the start of drug administration)&#xD;
&#xD;
          -  Smoker (&gt;10 cigarettes or &gt;3 cigars or &gt;3 pipes/day and who cannot refrain from&#xD;
             smoking at the trial site)&#xD;
&#xD;
          -  Alcohol abuse (&gt;40 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (≥100 mL within 4 weeks before drug administration or during the trial)&#xD;
&#xD;
          -  Excessive physical activities from 7 days before the start of drug administration to&#xD;
             the end of this study&#xD;
&#xD;
          -  Any positive results in hepatitis B surface antigen (HBsAg), anti hepatitis B core&#xD;
             (HBc) antibodies, anti hepatitis C virus (HCV) antibodies and human immunodeficiency&#xD;
             virus (HIV) test&#xD;
&#xD;
        The following exclusion criteria are of special interest for this study:&#xD;
&#xD;
          -  Hypersensitivity to pramipexole or other dopamine agonists&#xD;
&#xD;
          -  Supine blood pressure at screening of systolic &lt;110 mmHg and diastolic &lt;60 mmHg&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 14, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pramipexole</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02264132
org study id: 248.607
nct id: NCT02264132
lead sponsor: 
The objectives of this study were to investigate relative BA at steady state and to
      investigate dose proportionality of pharmacokinetic parameters

      Relative BA at steady state:

        -  Pramipexole 0.375 mg ER tablet q.d. versus pramipexole 0.125 mg IR tablet t.i.d.

        -  Pramipexole 1.5 mg ER tablet q.d. versus pramipexole 0.5 mg IR tablet t.i.d.

      Dose proportionality of pharmacokinetic parameters:

      · Pramipexole ER dosages from 0.375 to 1.5 mg q.d.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
time frame: up to day 5
measure: AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.)
time frame: up to 24 hours after drug administration
measure: Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
time frame: up to 24 hours after drug administration
description: Relative BA
measure: AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
time frame: up to 24 hours after drug administration
description: Dose proportionality (only for ER)
measure: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
time frame: up to day 5
description: Dose proportionality (only for ER)
measure: Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
time frame: up to 24 hours after drug administration
description: Dose proportionality (only for ER)
measure: AUCτ,ss=AUC0-24,ss for ER (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ=24 hours)
time frame: up to 24 hours after drug administration
measure: AUC0-24,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (This parameter was calculated as 3 times of AUC0-8,ss.)
time frame: up to 24 hours after drug administration
measure: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
time frame: up to day 5
measure: Cmin,ss (minimum measured concentration of the analyte in plasma at steady state)
time frame: up to day 5
measure: PTF (peak-trough fluctuation)
time frame: up to day 5
measure: tmax,ss (time from last dosing to the maximum concentration of the analyte in plasma at steady state)
time frame: up to day 5
measure: Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
time frame: up to day 5
measure: Cavg (average concentration of the analyte in plasma at steady state)
time frame: up to day 5
measure: t1/2,ss (terminal half-life of the analyte in plasma at steady state)
time frame: up to day 5
measure: CL/F,ss (apparent clearance of the analyte in plasma at steady state after
time frame: up to day 5
measure: CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ)
time frame: up to day 5
measure: Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following oral administration)
time frame: up to day 5
measure: Ae0-24,ss (amount of analyte that is eliminated in urine from 0 to 24 hours at steady state)
time frame: up to 24 hours after drug administration
measure: Ae0-8,ss for IR (amount of analyte that is eliminated in urine from 0 to 8 hours at steady state)
time frame: up to 8 hours after drug administration
measure: AUC0-8,ss for IR (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 8 hours at steady state)
time frame: up to 8 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 7 days after last drug administration
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: Day 5
arm group label: Pramipexole ER tablet versus Pramipexole IR tablet
arm group type: Experimental
arm group label: Pramipexole IR tablet versus Pramipexole ER tablet
arm group type: Experimental
intervention type: Drug
intervention name: Pramipexole ER tablet
arm group label: Pramipexole ER tablet versus Pramipexole IR tablet
arm group label: Pramipexole IR tablet versus Pramipexole ER tablet
intervention type: Drug
intervention name: Pramipexole IR tablet
arm group label: Pramipexole ER tablet versus Pramipexole IR tablet
arm group label: Pramipexole IR tablet versus Pramipexole ER tablet
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Pramipexole