<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/NCT04502277</url>
  </required_header>
  <id_info>
    <org_study_id>Diflucan</org_study_id>
    <nct_id>NCT04502277</nct_id>
  </id_info>
  <brief_title>Bioavailability of Flucanazole</brief_title>
  <official_title>Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of 40mgm/ml 35 ml Suspension and Pfizer (Diflucan®) 40 mg/ml 35 ml Fluconazole Suspension of Participants Under Fed Condition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sutphin Drugs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sutphin Drugs</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the&#xD;
      Single-dose Relative Bioavailability of Flucanazole 40mgm/ml 35 ml Suspension and Pfizer&#xD;
      (Diflucan®) 40 mg/ml 35 ml Fluconazole Suspension Under Fed Condition&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is to be conducted as an open-label, randomized, single-dose, 2-way crossover,&#xD;
      relative bio availability study performed on 200 healthy adult volunteers. A total 200&#xD;
      subjects will be assessed for AUC for 72 hours after administration of flucanazole suspension&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Early 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bio availability</measure>
    <time_frame>24 hours</time_frame>
    <description>To measure the AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours after a single dose administration of Under Fed Condition</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Candidiasis</condition>
  <arm_group>
    <arm_group_label>Flucanazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Flucanazole 40mgm/ml 35 ml Suspension and to measure AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours Under Fed Condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diflucan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Diflucan 40mgm/ml 35 ml Suspension and to measure AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours Under Fed Condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluconazole Powder</intervention_name>
    <description>The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Diflucan 40mgm/ml 35 ml Suspension and to measure AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours Under Fed Condition</description>
    <arm_group_label>Diflucan</arm_group_label>
    <arm_group_label>Flucanazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria Male and females between the ages of 18 and 35 years&#xD;
&#xD;
          -  Healthy Individual&#xD;
&#xD;
          -  Able to swallow&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of significant:&#xD;
&#xD;
               -  cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal,&#xD;
                  endocrine, immunologic, dermatologic, neurologic or psychiatric disease.&#xD;
&#xD;
        In addition, history or presence of:&#xD;
&#xD;
        alcoholism or drug abuse within the past year; hypersensitivity or idiosyncratic reaction&#xD;
        to fluconazole or other azoles. Subjects who have used any drugs or other substances known&#xD;
        to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first&#xD;
        dose.&#xD;
&#xD;
        Subjects who have used any drugs or other substances known to be strong inducers of CYP&#xD;
        (cytochrome P450) enzymes within 30 days prior to first dose.&#xD;
&#xD;
        Subjects who have been anormal diet during the 30 days prior to the first dosing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ajau Prakash, Ph.D.</last_name>
    <phone>7185260310</phone>
    <email>sutphinrx@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sutphin Drugs</name>
      <address>
        <city>Jamaica</city>
        <state>New York</state>
        <zip>11435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lifein Multi-Specialty Hospital</name>
      <address>
        <city>Navsari</city>
        <state>Gujarat</state>
        <zip>396421</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</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>Candidiasis</mesh_term>
  </condition_browse>
  <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>
  </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/NCT04502277
org study id: Diflucan
nct id: NCT04502277
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the
      Single-dose Relative Bioavailability of Flucanazole 40mgm/ml 35 ml Suspension and Pfizer
      (Diflucan®) 40 mg/ml 35 ml Fluconazole Suspension Under Fed Condition
The study is to be conducted as an open-label, randomized, single-dose, 2-way crossover,
      relative bio availability study performed on 200 healthy adult volunteers. A total 200
      subjects will be assessed for AUC for 72 hours after administration of flucanazole suspension
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Bio availability
time frame: 24 hours
description: To measure the AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours after a single dose administration of Under Fed Condition
arm group label: Flucanazole
arm group type: Experimental
description: The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Flucanazole 40mgm/ml 35 ml Suspension and to measure AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours Under Fed Condition
arm group label: Diflucan
arm group type: Active Comparator
description: The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Diflucan 40mgm/ml 35 ml Suspension and to measure AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours Under Fed Condition
intervention type: Drug
intervention name: Fluconazole Powder
description: The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Diflucan 40mgm/ml 35 ml Suspension and to measure AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours Under Fed Condition
arm group label: Diflucan
arm group label: Flucanazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ajau Prakash, Ph.D.
phone: 7185260310
email: sutphinrx@gmail.com
facility: 
facility: 
country: India
country: United States
responsible party type: Sponsor
mesh term: Candidiasis
mesh term: Fluconazole
sharing ipd: No