<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/NCT02183480</url>
  </required_header>
  <id_info>
    <org_study_id>1218.33</org_study_id>
    <nct_id>NCT02183480</nct_id>
  </id_info>
  <brief_title>Dose Proportionality of Different Dose Strengths of Linagliptin Tablets After Oral Administration to Healthy Male and Female Volunteers</brief_title>
  <official_title>Assessment of Dose Proportionality of Different Dose Strengths of Linagliptin Tablets After Oral Administration to Healthy Male and Female Volunteers in an Open, Randomised, Multiple-dose, Three-period Crossover, Phase I Trial</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 assess the pharmacokinetics and dose proportionality of 1 mg, 2.5 mg and 5 mg&#xD;
      tablets of linagliptin&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2009</start_date>
  <primary_completion_date type="Actual">September 2009</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 (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin</measure>
    <time_frame>up to 168 hours after first drug administration at each visit</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin</measure>
    <time_frame>up to 168 hours after first drug administration at each visit</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cτ,ss (average measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin</measure>
    <time_frame>up to 168 hours after first drug administration at each visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1750</measure>
    <time_frame>up to 168 hours after first drug administration at each visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1750</measure>
    <time_frame>up to 168 hours after first drug administration at each visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 53 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>within 10 days after last study drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Linagliptin, low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Linagliptin, medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Linagliptin, high dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linagliptin, low dose</intervention_name>
    <arm_group_label>Linagliptin, low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linagliptin, medium dose</intervention_name>
    <arm_group_label>Linagliptin, medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linagliptin, high dose</intervention_name>
    <arm_group_label>Linagliptin, high dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female volunteers according to the following criteria: Based upon a&#xD;
             complete medical history, including the physical examination, vital signs (Blood&#xD;
             Pressure (BP), Pulse Rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory&#xD;
             tests&#xD;
&#xD;
          -  Age 18 to 55 years (inclusive)&#xD;
&#xD;
          -  BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (inclusive)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including BP, PR and ECG) deviating from&#xD;
             normal and of clinical relevance. Repeated measurement of a systolic blood pressure&#xD;
             greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg&#xD;
&#xD;
          -  Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders&#xD;
&#xD;
          -  Surgery of the gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of relevant allergy/hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#xD;
&#xD;
          -  Intake of drugs within one month or less than 10 half-lives of the respective drug&#xD;
             prior to first study drug administration except if a relevant interaction can be ruled&#xD;
             out&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 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;
          -  Alcohol abuse ( average consumption of more than 20 g/day in females and 30 g/day in&#xD;
             males)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
        For female subjects only:&#xD;
&#xD;
          -  Positive pregnancy test, pregnancy or planning to become pregnant during the study or&#xD;
             within 2 months after study completion&#xD;
&#xD;
          -  No adequate contraception during the study and until 1 month after study completion,&#xD;
             i.e. not any of the following: implants, injectables, combined oral contraceptives,&#xD;
             IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment,&#xD;
             vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or&#xD;
             surgical sterilisation (including hysterectomy). Females, who do not have a&#xD;
             vasectomised partner, are not sexually abstinent or surgically sterile will be asked&#xD;
             to use an additional barrier method (e.g. condom, diaphragm with spermicide)&#xD;
&#xD;
          -  Lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.33_U10-1139-01.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 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>Linagliptin</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/NCT02183480
org study id: 1218.33
nct id: NCT02183480
lead sponsor: 
Study to assess the pharmacokinetics and dose proportionality of 1 mg, 2.5 mg and 5 mg
      tablets of linagliptin
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin
time frame: up to 168 hours after first drug administration at each visit
measure: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin
time frame: up to 168 hours after first drug administration at each visit
measure: Cτ,ss (average measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of linagliptin
time frame: up to 168 hours after first drug administration at each visit
measure: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1750
time frame: up to 168 hours after first drug administration at each visit
measure: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1750
time frame: up to 168 hours after first drug administration at each visit
measure: Number of patients with adverse events
time frame: up to 53 days
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: within 10 days after last study drug administration
arm group label: Linagliptin, low dose
arm group type: Experimental
arm group label: Linagliptin, medium dose
arm group type: Experimental
arm group label: Linagliptin, high dose
arm group type: Active Comparator
intervention type: Drug
intervention name: Linagliptin, low dose
arm group label: Linagliptin, low dose
intervention type: Drug
intervention name: Linagliptin, medium dose
arm group label: Linagliptin, medium dose
intervention type: Drug
intervention name: Linagliptin, high dose
arm group label: Linagliptin, high dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.33_U10-1139-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Linagliptin