<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/NCT01704846</url>
  </required_header>
  <id_info>
    <org_study_id>1220.53</org_study_id>
    <nct_id>NCT01704846</nct_id>
  </id_info>
  <brief_title>Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules</brief_title>
  <official_title>Assessment of Bioequivalence Between Two Different Formulations of BI 201335 NA Soft Gelatine Capsules in Healthy Male Volunteers. (an Open-label, Randomised, Single-dose, Four-period Replicated Crossover Study)</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 objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI&#xD;
      201335 NA soft gelatine capsules.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)</measure>
    <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
    <description>Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.&#xD;
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Measured Concentration (Cmax)</measure>
    <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
    <description>Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)</measure>
    <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
    <description>Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.&#xD;
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Dosing to the Maximum Measured Concentration (Tmax)</measure>
    <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
    <description>Time from dosing to the maximum measured concentration of the analyte in plasma.&#xD;
Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Rate Constant (λz)</measure>
    <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
    <description>Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Half-life (t1/2)</measure>
    <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
    <description>Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Residence Time (MRTpo)</measure>
    <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
    <description>Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Treatment sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test - Reference - Reference - Test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reference - Test - Test - Reference</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 201335 NA 120 mg capsule</intervention_name>
    <description>1capsule of BI 201335 NA 120 mg capsule</description>
    <arm_group_label>Treatment sequence 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 201335 NA 120 mg capsule</intervention_name>
    <description>1 capsule of BI 201335 NA 120 mg capsule</description>
    <arm_group_label>Treatment sequence 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 201335 NA 40 mg capsule</intervention_name>
    <description>3 capsules of BI 201335 NA 40 mg capsule</description>
    <arm_group_label>Treatment sequence 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 201335 NA 40 mg capsule</intervention_name>
    <description>3 capsules of BI 201335 NA 40 mg capsule</description>
    <arm_group_label>Treatment sequence 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Healthy male volunteers without any clinical significant findings and complications&#xD;
&#xD;
          2. Age: 20 - 45 years&#xD;
&#xD;
          3. BMI: 18.5 - 25.0 kg/m2&#xD;
&#xD;
          4. Signed informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Any finding of the medical examination (including blood pressure, pulse rate and&#xD;
             electrocardiogram) deviating from normal and of clinical relevance.&#xD;
&#xD;
          2. Any evidence of a clinically relevant concomitant disease according to investigator's&#xD;
             clinical judgement.&#xD;
&#xD;
          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immunological or hormonal disorders.&#xD;
&#xD;
          4. History of jaundice&#xD;
&#xD;
          5. Surgery of the gastrointestinal tract (except appendectomy).&#xD;
&#xD;
          6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders.&#xD;
&#xD;
          7. History of relevant orthostatic hypotension, fainting spells or blackouts.&#xD;
&#xD;
          8. Chronic or relevant acute infections.&#xD;
&#xD;
          9. History of relevant allergy/hypersensitivity (including allergy to drug or its&#xD;
             excipients) according to investigator's clinical judgement.&#xD;
&#xD;
         10. Intake of drugs with a long half-life (&gt;24 hours) within at least one month or less&#xD;
             than 10 half-lives of the respective drug prior to administration or during the trial&#xD;
&#xD;
         11. Use of drugs which might reasonably influence the results (pharmacokinetic) of the&#xD;
             trial within at least 10 days prior to administration or during the trial.&#xD;
&#xD;
         12. Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial.&#xD;
&#xD;
         13. Smoking (&gt;10 cigarettes or &gt;3 cigars or &gt;3 pipes/day).&#xD;
&#xD;
         14. Inability to refrain from smoking during the trial.&#xD;
&#xD;
         15. Alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous&#xD;
             [equivalent to 540 mL] of sake).&#xD;
&#xD;
         16. Drug abuse.&#xD;
&#xD;
         17. Blood donation (more than 100 mL within four weeks prior to administration).&#xD;
&#xD;
         18. Excessive physical activities (within one week prior to administration).&#xD;
&#xD;
         19. Any laboratory value outside the reference range that is of clinical relevance&#xD;
             according to investigator's clinical judgement.&#xD;
&#xD;
         20. Any history of relevant liver diseases (for instance, disturbances of liver function,&#xD;
             Dubin-Johnson syndrome, Rotor syndrome, or previous liver tumours).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1220.53.08101 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Sumida-ku,Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <results_first_submitted>July 3, 2015</results_first_submitted>
  <results_first_submitted_qc>July 3, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 31, 2015</results_first_posted>
  <last_update_submitted>July 3, 2015</last_update_submitted>
  <last_update_submitted_qc>July 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Sequence 1</title>
          <description>Treatment sequence: Test - Reference - Reference - Test&#xD;
Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.&#xD;
Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.&#xD;
Treatments were separated by a washout period of at least 14 days.</description>
        </group>
        <group group_id="P2">
          <title>Treatment Sequence 2</title>
          <description>Treatment sequence: Reference - Test - Test - Reference&#xD;
Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.&#xD;
Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.&#xD;
Treatments were separated by a washout period of at least 14 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period 4</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment Sequence 1</title>
          <description>Treatment sequence: Test - Reference - Reference - Test&#xD;
Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.&#xD;
Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.&#xD;
Treatments were separated by a washout period of at least 14 days.</description>
        </group>
        <group group_id="B2">
          <title>Treatment Sequence 2</title>
          <description>Treatment sequence: Reference - Test - Test - Reference&#xD;
Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.&#xD;
Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.&#xD;
Treatments were separated by a washout period of at least 14 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </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="28.1" spread="5.7"/>
                    <measurement group_id="B2" value="30.1" spread="5.8"/>
                    <measurement group_id="B3" value="29.1" spread="5.8"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)</title>
        <description>Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.&#xD;
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
        <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
        <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product: Faldaprevir 40 mg x 3 Capsules</title>
            <description>Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
          <group group_id="O2">
            <title>Reference Product: Faldaprevir 120 mg x 1 Capsule</title>
            <description>Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)</title>
          <description>Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.&#xD;
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
          <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
          <units>ng·h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Observations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17297.157" spread="19.71"/>
                    <measurement group_id="O2" value="17216.514" spread="23.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.</non_inferiority_desc>
            <param_type>Adjusted Geometric Mean Ratio (%)</param_type>
            <param_value>100.47</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>95.90</ci_lower_limit>
            <ci_upper_limit>105.25</ci_upper_limit>
            <estimate_desc>Ratio calculated as Test product divided by reference product</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Measured Concentration (Cmax)</title>
        <description>Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
        <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
        <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product: Faldaprevir 40 mg x 3 Capsules</title>
            <description>Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
          <group group_id="O2">
            <title>Reference Product: Faldaprevir 120 mg x 1 Capsule</title>
            <description>Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Measured Concentration (Cmax)</title>
          <description>Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
          <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Observations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="943.868" spread="32.16"/>
                    <measurement group_id="O2" value="916.480" spread="39.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.</non_inferiority_desc>
            <param_type>Adjusted Geometric Mean Ratio (%)</param_type>
            <param_value>102.99</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>95.57</ci_lower_limit>
            <ci_upper_limit>110.98</ci_upper_limit>
            <estimate_desc>Ratio calculated as Test product divided by reference product</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)</title>
        <description>Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.&#xD;
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
        <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
        <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product: Faldaprevir 40 mg x 3 Capsules</title>
            <description>Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
          <group group_id="O2">
            <title>Reference Product: Faldaprevir 120 mg x 1 Capsule</title>
            <description>Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)</title>
          <description>Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.&#xD;
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
          <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Observations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18422.006" spread="19.07"/>
                    <measurement group_id="O2" value="18323.189" spread="23.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.</non_inferiority_desc>
            <param_type>Adjusted Geometric Mean Ratio (%)</param_type>
            <param_value>100.54</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>96.10</ci_lower_limit>
            <ci_upper_limit>105.18</ci_upper_limit>
            <estimate_desc>Ratio calculated as Test product divided by reference product</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Dosing to the Maximum Measured Concentration (Tmax)</title>
        <description>Time from dosing to the maximum measured concentration of the analyte in plasma.&#xD;
Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation.</description>
        <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
        <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product: Faldaprevir 40 mg x 3 Capsules</title>
            <description>Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
          <group group_id="O2">
            <title>Reference Product: Faldaprevir 120 mg x 1 Capsule</title>
            <description>Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Dosing to the Maximum Measured Concentration (Tmax)</title>
          <description>Time from dosing to the maximum measured concentration of the analyte in plasma.&#xD;
Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation.</description>
          <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Observations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.478" spread="25.60" lower_limit="2" upper_limit="8"/>
                    <measurement group_id="O2" value="4.585" spread="31.48" lower_limit="2" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the adjusted mean ratio was 80 to 125%.</non_inferiority_desc>
            <param_type>Adjusted Mean Ratio (%)</param_type>
            <param_value>97.66</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>91.54</ci_lower_limit>
            <ci_upper_limit>103.78</ci_upper_limit>
            <estimate_desc>Ratio calculated as Test product divided by reference product</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Rate Constant (λz)</title>
        <description>Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
        <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
        <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product: Faldaprevir 40 mg x 3 Capsules</title>
            <description>Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
          <group group_id="O2">
            <title>Reference Product: Faldaprevir 120 mg x 1 Capsule</title>
            <description>Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Rate Constant (λz)</title>
          <description>Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
          <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
          <units>1/h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Observations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0265" spread="9.91"/>
                    <measurement group_id="O2" value="0.0264" spread="6.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.</non_inferiority_desc>
            <param_type>Adjusted Geometric Mean Ratio (%)</param_type>
            <param_value>100.34</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>98.51</ci_lower_limit>
            <ci_upper_limit>102.20</ci_upper_limit>
            <estimate_desc>Ratio calculated as Test product divided by reference product</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Half-life (t1/2)</title>
        <description>Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
        <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
        <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product: Faldaprevir 40 mg x 3 Capsules</title>
            <description>Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
          <group group_id="O2">
            <title>Reference Product: Faldaprevir 120 mg x 1 Capsule</title>
            <description>Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Half-life (t1/2)</title>
          <description>Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
          <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
          <units>hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Observations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.204" spread="9.91"/>
                    <measurement group_id="O2" value="26.293" spread="6.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.</non_inferiority_desc>
            <param_type>Adjusted Geometric Mean Ratio (%)</param_type>
            <param_value>99.66</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>97.85</ci_lower_limit>
            <ci_upper_limit>101.51</ci_upper_limit>
            <estimate_desc>Ratio calculated as Test product divided by reference product</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Residence Time (MRTpo)</title>
        <description>Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
        <time_frame>3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration</time_frame>
        <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product: Faldaprevir 40 mg x 3 Capsules</title>
            <description>Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
          <group group_id="O2">
            <title>Reference Product: Faldaprevir 120 mg x 1 Capsule</title>
            <description>Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Residence Time (MRTpo)</title>
          <description>Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.</description>
          <population>Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.</population>
          <units>hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Observations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.948" spread="9.93"/>
                    <measurement group_id="O2" value="29.888" spread="9.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.</non_inferiority_desc>
            <param_type>Adjusted Geometric Mean Ratio (%)</param_type>
            <param_value>100.20</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>98.10</ci_lower_limit>
            <ci_upper_limit>102.34</ci_upper_limit>
            <estimate_desc>Ratio calculated as Test product divided by reference product</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Four treatment periods (Period 1 to 4) of 6 days for each (Days -1 to 5) + Washout period of at least 14 days between treatments</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Product: Faldaprevir 40 mg x 3 Capsules</title>
          <description>Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</description>
        </group>
        <group group_id="E2">
          <title>Reference Product: Faldaprevir 120 mg x 1 Capsule</title>
          <description>Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast</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="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MEDDRA 15.1</default_vocab>
        <default_assessment>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="7" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.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/NCT01704846
org study id: 1220.53
nct id: NCT01704846
lead sponsor: 
The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI
      201335 NA soft gelatine capsules.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)
time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
description: Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
measure: Maximum Measured Concentration (Cmax)
time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
description: Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
measure: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
description: Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.
Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
measure: Time From Dosing to the Maximum Measured Concentration (Tmax)
time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
description: Time from dosing to the maximum measured concentration of the analyte in plasma.
Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation.
measure: Terminal Rate Constant (λz)
time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
description: Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
measure: Terminal Half-life (t1/2)
time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
description: Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
measure: Mean Residence Time (MRTpo)
time frame: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
description: Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
arm group label: Treatment sequence 1
arm group type: Experimental
description: Test - Reference - Reference - Test
arm group label: Treatment sequence 2
arm group type: Experimental
description: Reference - Test - Test - Reference
intervention type: Drug
intervention name: BI 201335 NA 120 mg capsule
description: 1capsule of BI 201335 NA 120 mg capsule
arm group label: Treatment sequence 2
intervention type: Drug
intervention name: BI 201335 NA 120 mg capsule
description: 1 capsule of BI 201335 NA 120 mg capsule
arm group label: Treatment sequence 1
intervention type: Drug
intervention name: BI 201335 NA 40 mg capsule
description: 3 capsules of BI 201335 NA 40 mg capsule
arm group label: Treatment sequence 1
intervention type: Drug
intervention name: BI 201335 NA 40 mg capsule
description: 3 capsules of BI 201335 NA 40 mg capsule
arm group label: Treatment sequence 2
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Japan
url: http://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Hepatitis C
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 