<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/NCT02260024</url>
  </required_header>
  <id_info>
    <org_study_id>248.560</org_study_id>
    <nct_id>NCT02260024</nct_id>
  </id_info>
  <brief_title>In Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets Pramipexole in Healthy Male Volunteers</brief_title>
  <official_title>A Single Dose Five-way Cross-over Study to Establish an in Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets With 0.375 mg Pramipexole in 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 primary objective of the study was to estimate the magnitude of the error in the&#xD;
      prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data&#xD;
      applying the methods of IVIVC. The secondary objective of the study was to investigate&#xD;
      whether the intake of food 30 minutes prior to drug administration affects the systemic&#xD;
      exposure of pramipexole SR C2 or not&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2005</start_date>
  <primary_completion_date type="Actual">December 2005</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>AUC0-30 (area under the concentration time curve of pramipexole in blood plasma over the time interval 0 to 30 h after drug administration)</measure>
    <time_frame>Up to 30 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (maximum measured concentration of pramipexole in blood plasma)</measure>
    <time_frame>Up to 30 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-10 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to the median tmax in the fasted state)</measure>
    <time_frame>Up to 30 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-24 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to 24 h after drug administration),</measure>
    <time_frame>Up to 24 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞ (area under the concentration-time curve of pramipexole in blood plasma over the time interval from 0 extrapolated to infinity),</measure>
    <time_frame>Up to 30 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of pramipexole in blood plasma)</measure>
    <time_frame>Up to 30 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in blood plasma),</measure>
    <time_frame>Up to 30 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (terminal half-life of pramipexole in blood plasma)</measure>
    <time_frame>Up to 30 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (mean residence time of pramipexole in the body after oral administration)</measure>
    <time_frame>Up to 30 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of pramipexole in the blood plasma after extravascular administration)</measure>
    <time_frame>Up to 30 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)</measure>
    <time_frame>Up to 30 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)</measure>
    <time_frame>Up to 120 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>Number of subjects with clinically significant findings in vital signs</measure>
    <time_frame>Up to 7 days after last drug administration</time_frame>
    <description>pulse rate, blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in laboratory parameters</measure>
    <time_frame>Up to 7 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in physical examination</measure>
    <time_frame>Up to 7 days after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Pramipexole IR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pramipexole SR C2 in the fasted state</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pramipexole SR C2A in the fasted state</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pramipexole SR C2B in the fasted state</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pramipexole SR C in the fasted state</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pramipexole SR C2 in the fed state</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High fat, high caloric meal</intervention_name>
    <arm_group_label>Pramipexole SR C2 in the fed state</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole IR tablets</intervention_name>
    <arm_group_label>Pramipexole IR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole SR C</intervention_name>
    <arm_group_label>Pramipexole SR C in the fasted state</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole SR C2</intervention_name>
    <arm_group_label>Pramipexole SR C2 in the fasted state</arm_group_label>
    <arm_group_label>Pramipexole SR C2 in the fed state</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole SR C2A</intervention_name>
    <arm_group_label>Pramipexole SR C2A in the fasted state</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole SR C2B</intervention_name>
    <arm_group_label>Pramipexole SR C2B in the fasted state</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects as determined by results of the screening&#xD;
&#xD;
          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and&#xD;
             local legislation&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 50 years&#xD;
&#xD;
          -  BMI ≥ 18.5 and ≤ 29.9 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to pramipexole or to other dopamine agonists&#xD;
&#xD;
          -  Supine systolic blood pressure lower than 110 mmHg and supine diastolic blood pressure&#xD;
             lower than 60 mmHg at screening&#xD;
&#xD;
          -  Any finding of the medical examination (including blood pressure, pulse rate and ECG)&#xD;
             deviating from normal and 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) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant 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; 24:00 hours) within at least one month or&#xD;
             less than ten half-lives of the respective drug before enrolment in the study or&#xD;
             during the study&#xD;
&#xD;
          -  Use of any drugs which might influence the results of the trial up to 7 days prior to&#xD;
             enrolment in the study or during the study&#xD;
&#xD;
          -  Participation in another trial with an investigational drug (≤ two months prior to&#xD;
             administration or during the trial)&#xD;
&#xD;
          -  Smoker (&gt; 10 cigarettes or &gt; 3 cigars or &gt; 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on in-house trial days&#xD;
&#xD;
          -  Alcohol abuse (&gt; 60 g/day)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (≥ 100 mL within four weeks prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the clinically accepted reference range&#xD;
&#xD;
          -  Excessive physical activities within the last week before the trial or during the&#xD;
             trial&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 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 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 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/NCT02260024
org study id: 248.560
nct id: NCT02260024
lead sponsor: 
The primary objective of the study was to estimate the magnitude of the error in the
      prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data
      applying the methods of IVIVC. The secondary objective of the study was to investigate
      whether the intake of food 30 minutes prior to drug administration affects the systemic
      exposure of pramipexole SR C2 or not
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-30 (area under the concentration time curve of pramipexole in blood plasma over the time interval 0 to 30 h after drug administration)
time frame: Up to 30 hours after drug administration
measure: Cmax (maximum measured concentration of pramipexole in blood plasma)
time frame: Up to 30 hours after drug administration
measure: AUC0-10 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to the median tmax in the fasted state)
time frame: Up to 30 hours after drug administration
measure: AUC0-24 (area under concentration-time curve of pramipexole in blood plasma over the time interval from 0 to 24 h after drug administration),
time frame: Up to 24 hours after drug administration
measure: AUC0-∞ (area under the concentration-time curve of pramipexole in blood plasma over the time interval from 0 extrapolated to infinity),
time frame: Up to 30 hours after drug administration
measure: tmax (time from dosing to the maximum concentration of pramipexole in blood plasma)
time frame: Up to 30 hours after drug administration
measure: λz (terminal rate constant in blood plasma),
time frame: Up to 30 hours after drug administration
measure: t½ (terminal half-life of pramipexole in blood plasma)
time frame: Up to 30 hours after drug administration
measure: MRTpo (mean residence time of pramipexole in the body after oral administration)
time frame: Up to 30 hours after drug administration
measure: CL/F (apparent clearance of pramipexole in the blood plasma after extravascular administration)
time frame: Up to 30 hours after drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase (λz) following an extravascular dose)
time frame: Up to 30 hours after drug administration
measure: Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
time frame: Up to 120 hours after drug administration
measure: Number of subjects with adverse events
time frame: Up to 7 days after last drug administration
measure: Number of subjects with clinically significant findings in vital signs
time frame: Up to 7 days after last drug administration
description: pulse rate, blood pressure
measure: Number of subjects with clinically significant findings in laboratory parameters
time frame: Up to 7 days after last drug administration
measure: Number of subjects with clinically significant findings in physical examination
time frame: Up to 7 days after last drug administration
arm group label: Pramipexole IR
arm group type: Active Comparator
arm group label: Pramipexole SR C2 in the fasted state
arm group type: Experimental
arm group label: Pramipexole SR C2A in the fasted state
arm group type: Experimental
arm group label: Pramipexole SR C2B in the fasted state
arm group type: Experimental
arm group label: Pramipexole SR C in the fasted state
arm group type: Experimental
arm group label: Pramipexole SR C2 in the fed state
arm group type: Experimental
intervention type: Other
intervention name: High fat, high caloric meal
arm group label: Pramipexole SR C2 in the fed state
intervention type: Drug
intervention name: Pramipexole IR tablets
arm group label: Pramipexole IR
intervention type: Drug
intervention name: Pramipexole SR C
arm group label: Pramipexole SR C in the fasted state
intervention type: Drug
intervention name: Pramipexole SR C2
arm group label: Pramipexole SR C2 in the fasted state
arm group label: Pramipexole SR C2 in the fed state
intervention type: Drug
intervention name: Pramipexole SR C2A
arm group label: Pramipexole SR C2A in the fasted state
intervention type: Drug
intervention name: Pramipexole SR C2B
arm group label: Pramipexole SR C2B in the fasted state
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Pramipexole