<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/NCT03821480</url>
  </required_header>
  <id_info>
    <org_study_id>A0561026</org_study_id>
    <nct_id>NCT03821480</nct_id>
  </id_info>
  <brief_title>Diflucan Bioequivalence Study For Transferring The Manufacture</brief_title>
  <official_title>AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER PIVOTAL BIOEQUIVALENCE STUDY OF FLUCONAZOLE CAPSULE 50 MG IN HEALTHY ADULT SUBJECTS</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to assess the bioequivalence between fluconazole 50mg capsules from two&#xD;
      different manufacturers. This is a open-label, randomized, single dose, 2-treatment, 2-period&#xD;
      crossover study in healthy Korean male and female subjects aged 19-55, to assess the&#xD;
      bioequivalence after taking study drugs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty-eight (28) healthy subjects will be enrolled into the study. Screening evaluation will&#xD;
      occur within 28 days prior to the first dose of study medication.&#xD;
&#xD;
      Subjects will be randomized to the following treatments:&#xD;
&#xD;
        -  Treatment A: Fluconazole capsule, 1 x 50 mg, Diflucan, West Ryde (REFERENCE)&#xD;
&#xD;
        -  Treatment B: Fluconazole capsule, 1 x 50 mg, Diflucan, Amboise (TEST)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">March 6, 2019</completion_date>
  <primary_completion_date type="Actual">March 6, 2019</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>
    <intervention_model_description>open-label, randomized, single dose, 2-treatment, 2-period crossover study</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1.Area Under Curve [AUC]last of fluconazole in Whole blood</measure>
    <time_frame>At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.</time_frame>
    <description>Area Under Curve(AUC) will be evaluated with Winnonlin analysis(Linear trapezoidal linear interpolation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2.Maximum Plasma Concentration [Cmax] of fluconazole in Whole blood</measure>
    <time_frame>At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.</time_frame>
    <description>Plasma concentrations of fluconazole will be assayed by a validated LC- MS/MS method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1.AUCinf</measure>
    <time_frame>At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.</time_frame>
    <description>Area under the plasma concentration-time profile from time zero extrapolated to infinite time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2.AUCt/AUCinf</measure>
    <time_frame>At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.</time_frame>
    <description>AUCt: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) AUCinf: Area under the plasma concentration-time profile from time zero extrapolated to infinite time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3.t½</measure>
    <time_frame>At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.</time_frame>
    <description>Half-life time of fluconazole</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>4.Tmax</measure>
    <time_frame>At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.</time_frame>
    <description>Time of Max concentration of fluconazole</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Bioequivalence</condition>
  <arm_group>
    <arm_group_label>Fluconazole 50 mg, Manufacturer: Amboise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluconazole 50mg, Manufacturer:West Ryde</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reference drug</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Test drug</intervention_name>
    <description>Fluconazole capsule 50 mg Manufacturer: West Ryde</description>
    <arm_group_label>Fluconazole 50 mg, Manufacturer: Amboise</arm_group_label>
    <other_name>Fluconazole capsule 50mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Reference drug</intervention_name>
    <description>Fluconazole capsule 50 mg Manufacturer: Amboise</description>
    <arm_group_label>Fluconazole 50mg, Manufacturer:West Ryde</arm_group_label>
    <other_name>Fluconazole capsule 50mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Healthy male and subjects who are between the ages of 19 and 55 years.&#xD;
&#xD;
          -  Female subjects who are found not to be pregnant in physical examinations&#xD;
&#xD;
          -  BMI of 17.5 to 30.5 kg/m2; and a total body weight &gt;50 kg (110 lb).&#xD;
&#xD;
          -  Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the subject has been informed of all pertinent aspects of the study.&#xD;
&#xD;
          -  Subjects who are willing and able to comply with all study procedures.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Evidence or history of clinically significant disease&#xD;
&#xD;
          -  Any condition possibly affecting drug absorption (eg, gastrectomy).&#xD;
&#xD;
          -  A positive urine drug test.&#xD;
&#xD;
          -  History of regular alcohol consumption exceeding standard for the study&#xD;
&#xD;
          -  Treatment with an investigational drug within 3 months or 5 half-lives preceding the&#xD;
             first dose of investigational product (whichever is longer).&#xD;
&#xD;
          -  Screening seated BP 140 mm Hg (systolic) or 90 mm Hg (diastolic) and over&#xD;
&#xD;
          -  Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval over 450 msec&#xD;
             or a QRS interval over 120 msec.&#xD;
&#xD;
          -  Subjects with ANY of the following abnormalities in clinical laboratory tests at&#xD;
             screening, when assessed by the study-specific laboratory and confirmed by a single&#xD;
             repeat test:&#xD;
&#xD;
             • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level over 2&#xD;
             upper limit of normal (ULN); Total bilirubin level 2.0 mg/mL and over; subjects with a&#xD;
             history of Gilbert's syndrome may have direct bilirubin measured and would be eligible&#xD;
             for this study provided the direct bilirubin level is same or under ULN.&#xD;
&#xD;
          -  Pregnant female subjects, breastfeeding female subjects, male subjects, who are&#xD;
             fertile enough and female subjects of childbearing potential for at least 28 days&#xD;
             after the last dose of investigational product.&#xD;
&#xD;
          -  Use of prescription or nonprescription drugs and dietary supplements within 10 days or&#xD;
             5 half-lives (whichever is longer) prior to the first dose of investigational product.&#xD;
&#xD;
          -  Use of any drugs known to significantly induce (e.g., barbiturates) or inhibit drug-&#xD;
             metabolizing enzymes or excessive alcohol consumption within one month prior to the&#xD;
             time of screening.&#xD;
&#xD;
          -  Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more&#xD;
             within 60 days prior to dosing.&#xD;
&#xD;
          -  History of sensitivity to heparin or heparin-induced thrombocytopenia.&#xD;
&#xD;
          -  History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), human&#xD;
             immunodeficiency virus (HIV) antigen or antibody, and/or syphilis (RPR, Rapid Plasma&#xD;
             Reagin test).&#xD;
&#xD;
          -  Unwilling or unable to comply with the criteria in the Lifestyle Requirements section&#xD;
             of this protocol.&#xD;
&#xD;
          -  Subjects who are investigator site staff members directly involved in the conduct of&#xD;
             the study and their family members, site staff members otherwise supervised by the&#xD;
             investigator, or subjects who are Pfizer employees, including their family members,&#xD;
             directly involved in the conduct of the study.&#xD;
&#xD;
          -  Other acute or chronic medical or psychiatric condition&#xD;
&#xD;
          -  Subjects with known sensitivity to the drug or any of the insert ingredients or to&#xD;
             related azole compounds.&#xD;
&#xD;
          -  Subjects with hereditary problems of galactose intolerance, Lapp lactase deficiency or&#xD;
             glucose-galactose malabsorption.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 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>Chungnam National University Hospital, Clinical Trials Center</name>
      <address>
        <city>Daejeon</city>
        <zip>35015</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0561026&amp;StudyName=AN+OPEN-LABEL%2C+RANDOMIZED%2C+SINGLE+DOSE%2C+CROSSOVER+PIVOTAL+BIOEQUIVALENCE+STUDY+OF+FLUCONAZOLE+CAPSULE+50+MG+IN+HEALTHY+ADULT+SUBJECTS</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>July 15, 2021</last_update_submitted>
  <last_update_submitted_qc>July 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fluconazole</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <!-- 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/NCT03821480
org study id: A0561026
nct id: NCT03821480
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to assess the bioequivalence between fluconazole 50mg capsules from two
      different manufacturers. This is a open-label, randomized, single dose, 2-treatment, 2-period
      crossover study in healthy Korean male and female subjects aged 19-55, to assess the
      bioequivalence after taking study drugs.
Twenty-eight (28) healthy subjects will be enrolled into the study. Screening evaluation will
      occur within 28 days prior to the first dose of study medication.

      Subjects will be randomized to the following treatments:

        -  Treatment A: Fluconazole capsule, 1 x 50 mg, Diflucan, West Ryde (REFERENCE)

        -  Treatment B: Fluconazole capsule, 1 x 50 mg, Diflucan, Amboise (TEST)
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: open-label, randomized, single dose, 2-treatment, 2-period crossover study
primary purpose: Basic Science
masking: None (Open Label)
measure: 1.Area Under Curve [AUC]last of fluconazole in Whole blood
time frame: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.
description: Area Under Curve(AUC) will be evaluated with Winnonlin analysis(Linear trapezoidal linear interpolation).
measure: 2.Maximum Plasma Concentration [Cmax] of fluconazole in Whole blood
time frame: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.
description: Plasma concentrations of fluconazole will be assayed by a validated LC- MS/MS method.
measure: 1.AUCinf
time frame: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.
description: Area under the plasma concentration-time profile from time zero extrapolated to infinite time
measure: 2.AUCt/AUCinf
time frame: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.
description: AUCt: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) AUCinf: Area under the plasma concentration-time profile from time zero extrapolated to infinite time
measure: 3.t½
time frame: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.
description: Half-life time of fluconazole
measure: 4.Tmax
time frame: At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.
description: Time of Max concentration of fluconazole
arm group label: Fluconazole 50 mg, Manufacturer: Amboise
arm group type: Experimental
description: Test drug
arm group label: Fluconazole 50mg, Manufacturer:West Ryde
arm group type: Active Comparator
description: Reference drug
intervention type: Drug
intervention name: Test drug
description: Fluconazole capsule 50 mg Manufacturer: West Ryde
arm group label: Fluconazole 50 mg, Manufacturer: Amboise
other name: Fluconazole capsule 50mg
intervention type: Drug
intervention name: Reference drug
description: Fluconazole capsule 50 mg Manufacturer: Amboise
arm group label: Fluconazole 50mg, Manufacturer:West Ryde
other name: Fluconazole capsule 50mg
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: Korea, Republic of
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0561026&StudyName=AN+OPEN-LABEL%2C+RANDOMIZED%2C+SINGLE+DOSE%2C+CROSSOVER+PIVOTAL+BIOEQUIVALENCE+STUDY+OF+FLUCONAZOLE+CAPSULE+50+MG+IN+HEALTHY+ADULT+SUBJECTS
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Fluconazole
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.