<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/NCT02261090</url>
  </required_header>
  <id_info>
    <org_study_id>248.529</org_study_id>
    <nct_id>NCT02261090</nct_id>
  </id_info>
  <brief_title>Bioavailability of Different Pramipexole Slow-release Formulations Compared to Immediate-release Tablet in Healthy Male Volunteers</brief_title>
  <official_title>A Multiple Dose Seven-way Cross-over Formulation-finding Study Comparing the Oral Bioavailability of Seven Prototype Slow-release Formulations With 0.75 mg Pramipexole (Four Days Each) to Immediate-release Tablets at Steady State 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>
      Study to compare the oral bioavailability of seven prototype slow-release formulations to&#xD;
      immediate-release tablets&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2004</start_date>
  <primary_completion_date type="Actual">September 2004</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>Plasma total exposure (AUCτ,ss)</measure>
    <time_frame>up to 168 hours after each drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine total exposure (Aeτ,ss)</measure>
    <time_frame>up to 168 hours after each drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma maximum exposure (Cmax,ss)</measure>
    <time_frame>up to 168 hours after each drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma minimum exposure (Cmin,ss)</measure>
    <time_frame>up to 168 hours after each drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma average concentration (Cavg)</measure>
    <time_frame>up to 168 hours after each drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma peak to trough fluctuation (PTF)</measure>
    <time_frame>up to 168 hours after each drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-6,11 for the immediate release (IR) formulation</measure>
    <time_frame>day 7 of visit 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax for the IR formulation</measure>
    <time_frame>up to 168 hours after drug administration in visit 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin for the IR formulation</measure>
    <time_frame>up to 168 hours after drug administration in visit 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax for the IR formulation</measure>
    <time_frame>up to 168 hours after drug administration in visit 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary excretion (Ae) for the IR formulation</measure>
    <time_frame>up to 168 hours after drug administration in visit 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax,4 for the SR formulation</measure>
    <time_frame>up to 96 hours after drug administration in visit 3-5, 7 and 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2,4 for the SR formulation</measure>
    <time_frame>up to 96 hours after drug administration in visit 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary excretion (Ae) for the SR formulation</measure>
    <time_frame>up to 168 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 8 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with clinically significant findings in laboratory tests</measure>
    <time_frame>up to 8 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 8 days after last drug administration</time_frame>
    <description>blood pressure, pulse rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of global tolerability by investigator on a 5-point scale</measure>
    <time_frame>at the end of each of the visits 2 to 9</time_frame>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Formulation B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Slow release (SR) tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formulation C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SR tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formulation D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SR tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formulation E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SR tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formulation F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SR tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formulation G</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SR tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formulation H</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SR tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>immediate release (IR) formulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Formulation B: Pramipexole Slow release (SR) tablet</intervention_name>
    <arm_group_label>Formulation B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Formulation C: Pramipexole Slow release tablet</intervention_name>
    <arm_group_label>Formulation C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Formulation D: Pramipexole Slow release tablet</intervention_name>
    <arm_group_label>Formulation D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Formulation E: Pramipexole Slow release tablet</intervention_name>
    <arm_group_label>Formulation E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Formulation F: Pramipexole Slow release tablet</intervention_name>
    <arm_group_label>Formulation F</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Formulation G: Pramipexole Slow release tablet</intervention_name>
    <arm_group_label>Formulation G</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Formulation H: Pramipexole Slow release tablet</intervention_name>
    <arm_group_label>Formulation H</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole immediate release (IR) tablets</intervention_name>
    <arm_group_label>immediate release (IR) formulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants in the study should be healthy males&#xD;
&#xD;
          -  Participants should be ranging from 21 to 50 years of age&#xD;
&#xD;
          -  Body mass index (BMI) within 18.5 to 29.9 kg/m2&#xD;
&#xD;
          -  In accordance with Good Clinical Practice and the local legislation all volunteers&#xD;
             will have given their written informed consent prior to admission to the study&#xD;
&#xD;
        Exclusion Criteria:&#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;
&#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;
&#xD;
          -  A haemoglobin value at screening of less than 13.5 g/dl (usual lower limit of normal&#xD;
             for males: 12.6 g/mL)&#xD;
&#xD;
          -  Subjects involved in passenger transport or operation of dangerous machines&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 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 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 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/NCT02261090
org study id: 248.529
nct id: NCT02261090
lead sponsor: 
Study to compare the oral bioavailability of seven prototype slow-release formulations to
      immediate-release tablets
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma total exposure (AUCτ,ss)
time frame: up to 168 hours after each drug administration
measure: Urine total exposure (Aeτ,ss)
time frame: up to 168 hours after each drug administration
measure: Plasma maximum exposure (Cmax,ss)
time frame: up to 168 hours after each drug administration
measure: Plasma minimum exposure (Cmin,ss)
time frame: up to 168 hours after each drug administration
measure: Plasma average concentration (Cavg)
time frame: up to 168 hours after each drug administration
measure: Plasma peak to trough fluctuation (PTF)
time frame: up to 168 hours after each drug administration
measure: AUC0-6,11 for the immediate release (IR) formulation
time frame: day 7 of visit 2
measure: Cmax for the IR formulation
time frame: up to 168 hours after drug administration in visit 2
measure: Cmin for the IR formulation
time frame: up to 168 hours after drug administration in visit 2
measure: tmax for the IR formulation
time frame: up to 168 hours after drug administration in visit 2
measure: Urinary excretion (Ae) for the IR formulation
time frame: up to 168 hours after drug administration in visit 2
measure: tmax,4 for the SR formulation
time frame: up to 96 hours after drug administration in visit 3-5, 7 and 9
measure: t1/2,4 for the SR formulation
time frame: up to 96 hours after drug administration in visit 9
measure: Urinary excretion (Ae) for the SR formulation
time frame: up to 168 hours after drug administration
measure: Number of subjects with adverse events
time frame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
time frame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in vital signs
time frame: up to 8 days after last drug administration
description: blood pressure, pulse rate
measure: Assessment of global tolerability by investigator on a 5-point scale
time frame: at the end of each of the visits 2 to 9
arm group label: Formulation B
arm group type: Experimental
description: Slow release (SR) tablet
arm group label: Formulation C
arm group type: Experimental
description: SR tablet
arm group label: Formulation D
arm group type: Experimental
description: SR tablet
arm group label: Formulation E
arm group type: Experimental
description: SR tablet
arm group label: Formulation F
arm group type: Experimental
description: SR tablet
arm group label: Formulation G
arm group type: Experimental
description: SR tablet
arm group label: Formulation H
arm group type: Experimental
description: SR tablet
arm group label: immediate release (IR) formulation
arm group type: Active Comparator
intervention type: Drug
intervention name: Formulation B: Pramipexole Slow release (SR) tablet
arm group label: Formulation B
intervention type: Drug
intervention name: Formulation C: Pramipexole Slow release tablet
arm group label: Formulation C
intervention type: Drug
intervention name: Formulation D: Pramipexole Slow release tablet
arm group label: Formulation D
intervention type: Drug
intervention name: Formulation E: Pramipexole Slow release tablet
arm group label: Formulation E
intervention type: Drug
intervention name: Formulation F: Pramipexole Slow release tablet
arm group label: Formulation F
intervention type: Drug
intervention name: Formulation G: Pramipexole Slow release tablet
arm group label: Formulation G
intervention type: Drug
intervention name: Formulation H: Pramipexole Slow release tablet
arm group label: Formulation H
intervention type: Drug
intervention name: Pramipexole immediate release (IR) tablets
arm group label: immediate release (IR) formulation
criteria: 
gender: Male
minimum age: 21 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