<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/NCT02217813</url>
  </required_header>
  <id_info>
    <org_study_id>B3461044</org_study_id>
    <secondary_id>2014-003271-35</secondary_id>
    <nct_id>NCT02217813</nct_id>
  </id_info>
  <brief_title>A Bioequivalence Study Comparing Two Different Tafamidis Formulations</brief_title>
  <official_title>A Phase 1, Open-label, Randomized, Crossover, Single Dose Study To Determine The Bioequivalence Of Pf-06291826 (Tafamidis) 20 Mg Capsule Manufactured By Catalent Versus Capsule Manufactured By Pii In Healthy Subjects Under Fasted Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis&#xD;
      blood concentrations will be measured periodically for one week. After about 20 days,&#xD;
      subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis&#xD;
      concentrations from the two different formulations will be compared to determine if they are&#xD;
      approximately the same.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the Concentration-Time Curve (AUC)</measure>
    <time_frame>168 hours</time_frame>
    <description>AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>168 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]</measure>
    <time_frame>168 hours</time_frame>
    <description>AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>168 hours</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
    <time_frame>168 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2)</measure>
    <time_frame>168 hours</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>1. Tafamidis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>2. Tafamidis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tafamidis</intervention_name>
    <description>20 mg of current commercial formulation</description>
    <arm_group_label>1. Tafamidis</arm_group_label>
    <other_name>Vyndaqel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tafamidis</intervention_name>
    <description>20 mg of new formulation</description>
    <arm_group_label>2. Tafamidis</arm_group_label>
    <other_name>Vyndaqel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or females of non-child bearing potential.&#xD;
&#xD;
          -  Body Mass Index (BMI) of 17.5 to 30.5 Kg and total body weight more than 50 Kg (110&#xD;
             lbs).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies at time of dosing).&#xD;
&#xD;
          -  Use of prescription or nonprescription drugs and dietary supplements within 7 days or&#xD;
             5 half lives (whichever is longer) prior to the first dose of study medication.&#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>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pfizer Clinical Research Unit</name>
      <address>
        <city>Brussels</city>
        <zip>B-1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3461044&amp;StudyName=A%20Bioequivalence%20Study%20Comparing%20Two%20Different%20Tafamidis%20Formulations</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>January 6, 2015</last_update_submitted>
  <last_update_submitted_qc>January 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02217813
org study id: B3461044
secondary id: 2014-003271-35
nct id: NCT02217813
lead sponsor: 
has dmc: No
Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis
      blood concentrations will be measured periodically for one week. After about 20 days,
      subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis
      concentrations from the two different formulations will be compared to determine if they are
      approximately the same.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area under the Concentration-Time Curve (AUC)
time frame: 168 hours
description: AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: 168 hours
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
time frame: 168 hours
description: AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: 168 hours
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: 168 hours
measure: Plasma Decay Half-Life (t1/2)
time frame: 168 hours
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
arm group label: 1. Tafamidis
arm group type: Experimental
arm group label: 2. Tafamidis
arm group type: Experimental
intervention type: Drug
intervention name: Tafamidis
description: 20 mg of current commercial formulation
arm group label: 1. Tafamidis
other name: Vyndaqel
intervention type: Drug
intervention name: Tafamidis
description: 20 mg of new formulation
arm group label: 2. Tafamidis
other name: Vyndaqel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: Belgium
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3461044&StudyName=A%20Bioequivalence%20Study%20Comparing%20Two%20Different%20Tafamidis%20Formulations
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor