<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/NCT04406194</url>
  </required_header>
  <id_info>
    <org_study_id>NOV2020/1917</org_study_id>
    <nct_id>NCT04406194</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions</brief_title>
  <acronym>Favipiravir</acronym>
  <official_title>Open-label,Randomised,Single Oral Dose,Two-period,Cross-over Trial to Assess to Bioequivalence of Favicovir 200 mg FT in Comparison With Avigan 200 mg FT in Healthy Male Subjects Under Fasting Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Atabay Kimya Sanayi Ticaret A.S.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novagenix Bioanalytical Drug R&amp;D Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Farmagen Ar-Ge Biyot. Ltd. Sti</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Atabay Kimya Sanayi Ticaret A.S.</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>
      A single dose of Reference product containing 200 mg favipiravir and a single dose of Test&#xD;
      product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at&#xD;
      room temperature, in each period under fasting conditions with current pandemic precautions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Favipiravir is a drug with a mechanism of action different from that of the existing&#xD;
      influenza antiviral drugs and effective against all types and sub-types of human influenza A,&#xD;
      B and C viruses in vitro, showing anti-viral activity against various influenza virus strains&#xD;
      including avian and swine viruses. Favipiravir also has shown anti-viral activity even&#xD;
      against amantadine, oseltamivir and zanamivir-resistant influenza viruses in vitro. The&#xD;
      mechanism of action of favipiravir is the selective inhibition of RNA polymerase by&#xD;
      favipiravir ribosyl triphosphate formed by cellular enzymes in the influenza virus leading to&#xD;
      antiviral activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 14, 2020</start_date>
  <completion_date type="Actual">June 19, 2020</completion_date>
  <primary_completion_date type="Actual">May 22, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-tlast of Favipiravir</measure>
    <time_frame>0 to 24 hours post-dose</time_frame>
    <description>Area under the concentration-time curve of favipiravir in plasma over the time interval from 0 to 24 hours</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Favipiravir</measure>
    <time_frame>0 to 24 hours post-dose</time_frame>
    <description>Maximum plasma concentration of favipiravir</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC0-inf of Favipiravir</measure>
    <time_frame>0 to 24 hours post-dose</time_frame>
    <description>Area under the plasma concentration curve to infinite time of favipiravir</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of Favipiravir</measure>
    <time_frame>0 to 24 hours post-dose</time_frame>
    <description>Time to reach maximum plasma concentration of favipiravir</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Bioequivalence</condition>
  <arm_group>
    <arm_group_label>FAVICOVIR then AVIGAN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants first received Favicovir 200 mg FT manufactured by Atabay in a fasting state. After a washout period of 48 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AVIGAN then FAVICOVIR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants first received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favicovir 200 mg FT manufactured by Atabay in a fasting state.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FAVICOVIR 200 mg Film Tablet</intervention_name>
    <description>FAVICOVIR 200 MG FT is containing 200 mg favipiravir manufactured by Atabay, Turkey.</description>
    <arm_group_label>AVIGAN then FAVICOVIR</arm_group_label>
    <arm_group_label>FAVICOVIR then AVIGAN</arm_group_label>
    <other_name>Favipiravir 200 MG FT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AVIGAN 200 mg Film Tablets</intervention_name>
    <description>AVIGAN 200 mg FT is containing 200 mg favipiravir manufactured by Toyama, Japan.</description>
    <arm_group_label>AVIGAN then FAVICOVIR</arm_group_label>
    <arm_group_label>FAVICOVIR then AVIGAN</arm_group_label>
    <other_name>Favipiravir 200 mg FT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy Caucasian male subjects aged between 20 and 40 years&#xD;
&#xD;
          2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink&#xD;
             coffee during the study period&#xD;
&#xD;
          3. Two Negative Covid-19 PCR test results&#xD;
&#xD;
          4. Negative alcohol breath test results&#xD;
&#xD;
          5. Normal physical examination at screening visit&#xD;
&#xD;
          6. Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in&#xD;
             the desirable range according to the age&#xD;
&#xD;
          7. Ability to communicate adequately with the investigator himself or his representatives&#xD;
&#xD;
          8. Ability and agreement to comply with the study requirements&#xD;
&#xD;
          9. Normal blood pressure and heart rate measured under stabilised conditions at the&#xD;
             screening visit after at least 5 minutes of rest under supine position: SBP within 100&#xD;
             to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm&#xD;
&#xD;
         10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of&#xD;
             rest&#xD;
&#xD;
         11. Laboratory results within normal range or clinically non-significant (CBC, glucose,&#xD;
             urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium,&#xD;
             calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein&#xD;
             and urinalysis), drug addiction scanning in urine results in negative (amphetamine,&#xD;
             barbiturate, benzodiazepine, cannabinoid, cocaine, opiate)&#xD;
&#xD;
         12. Understanding of the study and agreement to give a written informed consent according&#xD;
             to section 20.3&#xD;
&#xD;
         13. Understanding of that he and his partner will use a practice adequate contraception&#xD;
             during the study and at least 7 days after the study&#xD;
&#xD;
         14. Volunteer's compliance with isolation rules defined at study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Who have atopic constitution or asthma or known allergy for favipiravir and/or any&#xD;
             other ingredients of the products.&#xD;
&#xD;
          2. Any history or presence of clinical relevance of cardiovascular, neurological,&#xD;
             musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary,&#xD;
             endocrinological, metabolism or psychiatric disease, any type of porphyria.&#xD;
&#xD;
          3. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first&#xD;
             drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10&#xD;
             mmHg occurs between sitting/supine to standing position subject will be excluded (if&#xD;
             it deemed necessary by the investigator),&#xD;
&#xD;
          4. Presence or history of malabsorption or any gastrointestinal surgery except&#xD;
             appendectomy or except herniotomy.&#xD;
&#xD;
          5. Subjects who have given more than 400 mL blood within the last two months before the&#xD;
             first drug administration and subjects who have participated to any drug research&#xD;
             within the last two months before the first drug administration.&#xD;
&#xD;
          6. Subjects suspected to have a high probability of non-compliance to the study procedure&#xD;
             and/or completion of the study according to the investigator's judgement.&#xD;
&#xD;
          7. Subjects who used any of prescribed systemic or topical medication (including OTC&#xD;
             medication) within 2 weeks (or six elimination half lives of this medication,&#xD;
             whichever is longer) before the initiation of the study (except single doses of&#xD;
             analgesics which have no drug interaction with study product).&#xD;
&#xD;
          8. Use of any vitamins or herbal products within 7 days prior to the initial dose of the&#xD;
             study medication.&#xD;
&#xD;
          9. History of allergic response to heparin.&#xD;
&#xD;
         10. Subjects who have any chronic disease which might interfere with absorption,&#xD;
             distribution, metabolism or excretion of the drug.&#xD;
&#xD;
         11. Subjects who regular consumed of beverages or food containing methylxanthines (e.g.&#xD;
             coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg&#xD;
             methylxanthines per day.&#xD;
&#xD;
         12. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug&#xD;
             administration, during the study.&#xD;
&#xD;
         13. History of drug abuse.&#xD;
&#xD;
         14. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or&#xD;
             10 units per week and/or positive alcohol breath test results (Note: one unit of&#xD;
             alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits).&#xD;
&#xD;
         15. Positive blood test for HBV, HCV and HIV.&#xD;
&#xD;
         16. Who have relationship to the investigator.&#xD;
&#xD;
         17. Who are not suitable to any of inclusion criteria.&#xD;
&#xD;
         18. History of difficulty of swallowing.&#xD;
&#xD;
         19. Intake of depot injectable solutions (including study medications) within 6 months&#xD;
             before start of the study.&#xD;
&#xD;
         20. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before&#xD;
             start of the study.&#xD;
&#xD;
         21. Special diet due to any reason, e.g. vegetarian.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muradiye Nacak, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Farmagen Ar-Ge Biyot. Ltd. Sti</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novagenix Drug R&amp;D Center</name>
      <address>
        <city>Akyurt</city>
        <state>Ankara</state>
        <zip>06970</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Farmagen Ar-Ge Biyot. Ltd. Sti.</name>
      <address>
        <city>Sahinbey</city>
        <state>Gaziantep</state>
        <zip>27000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <results_first_submitted>June 10, 2020</results_first_submitted>
  <results_first_submitted_qc>August 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 12, 2020</results_first_posted>
  <last_update_submitted>August 13, 2020</last_update_submitted>
  <last_update_submitted_qc>August 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19 drug treatment</keyword>
  <keyword>Antiviral Agents</keyword>
  <keyword>Favipiravir</keyword>
  <keyword>Novagenix</keyword>
  <keyword>Farmagen</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Favipiravir</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT04406194/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT04406194/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>57 subject screened</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Experimental: FAVICOVIR Then AVIGAN</title>
          <description>Participants first received Favicovir 200 mg FT manufactured by Atabay in a fasting state. After a washout period of 48 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state.</description>
        </group>
        <group group_id="P2">
          <title>AVIGAN Then FAVICOVIR</title>
          <description>Participants first received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favicovir 200 mg FT manufactured by Atabay in a fasting state.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="14"/>
              </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>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="14"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>FAVICOVIR Then AVIGAN</title>
          <description>Participants first received Favicovir 200 mg FT manufactured by Atabay in a fasting state. After a washout period of 48 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state.</description>
        </group>
        <group group_id="B2">
          <title>AVIGAN Then FAVICOVIR</title>
          <description>Participants first received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favicovir 200 mg FT manufactured by Atabay in a fasting state.</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="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29" lower_limit="25" upper_limit="35"/>
                    <measurement group_id="B2" value="29" lower_limit="25" upper_limit="35"/>
                    <measurement group_id="B3" value="29" lower_limit="25" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </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="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>subjects</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>AUC0-tlast of Favipiravir</title>
        <description>Area under the concentration-time curve of favipiravir in plasma over the time interval from 0 to 24 hours</description>
        <time_frame>0 to 24 hours post-dose</time_frame>
        <population>29 subjects were analysed and included in statistical analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Favicovir 200 mg FT</title>
            <description>Participants received single oral dose of 200 mg favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.</description>
          </group>
          <group group_id="O2">
            <title>Avigan 200 mg FT</title>
            <description>Participants received single oral dose of 200 mg favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-tlast of Favipiravir</title>
          <description>Area under the concentration-time curve of favipiravir in plasma over the time interval from 0 to 24 hours</description>
          <population>29 subjects were analysed and included in statistical analysis.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9641.989" spread="2545.1"/>
                    <measurement group_id="O2" value="9907.170" spread="2423.5"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>0.80-1.25 margins for equivalence</non_inferiority_desc>
            <p_value>0.0000</p_value>
            <method>ANOVA</method>
            <param_type>Mean Ratio</param_type>
            <param_value>0.9684</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9400</ci_lower_limit>
            <ci_upper_limit>0.9977</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Favipiravir</title>
        <description>Maximum plasma concentration of favipiravir</description>
        <time_frame>0 to 24 hours post-dose</time_frame>
        <population>29 subjects were analysed and included in statistical analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Favicovir 200 mg FT</title>
            <description>Participants received single oral dose of 200 mg Favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.</description>
          </group>
          <group group_id="O2">
            <title>Avigan 200 mg FT</title>
            <description>Participants received single oral dose of 200 mg Favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Favipiravir</title>
          <description>Maximum plasma concentration of favipiravir</description>
          <population>29 subjects were analysed and included in statistical analysis.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5411.624" spread="2025.6"/>
                    <measurement group_id="O2" value="5002.171" spread="1231.1"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>0.80 - 1.25 equivalence margin is required.</non_inferiority_desc>
            <p_value>0.0155</p_value>
            <method>ANOVA</method>
            <param_type>Mean Ratio</param_type>
            <param_value>1.0555</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9292</ci_lower_limit>
            <ci_upper_limit>1.1989</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC0-inf of Favipiravir</title>
        <description>Area under the plasma concentration curve to infinite time of favipiravir</description>
        <time_frame>0 to 24 hours post-dose</time_frame>
        <population>29 subjects were analysed and included in statistical analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Favicovir 200 mg FT</title>
            <description>Participants received single oral dose of 200 mg favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.</description>
          </group>
          <group group_id="O2">
            <title>Avigan 200 mg FT</title>
            <description>Participants received single oral dose of 200 mg favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-inf of Favipiravir</title>
          <description>Area under the plasma concentration curve to infinite time of favipiravir</description>
          <population>29 subjects were analysed and included in statistical analysis.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9910.494" spread="2618.9"/>
                    <measurement group_id="O2" value="10152.115" spread="2507.694"/>
                  </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>Equivalence</non_inferiority_type>
            <non_inferiority_desc>0.80 - 1.25 equivalence margin is not required.</non_inferiority_desc>
            <p_value>0.0000</p_value>
            <method>ANOVA</method>
            <param_type>Mean Ratio</param_type>
            <param_value>0.9719</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9440</ci_lower_limit>
            <ci_upper_limit>1.0006</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax of Favipiravir</title>
        <description>Time to reach maximum plasma concentration of favipiravir</description>
        <time_frame>0 to 24 hours post-dose</time_frame>
        <population>29 subjects were analysed and included in statistical analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Favicovir 200 mg FT</title>
            <description>Participants received single dose of 200 mg Favipiravir (Favicovir 200 mg FT, Atabay-Turkey) under fasting conditions.</description>
          </group>
          <group group_id="O2">
            <title>Avigan 200 mg FT</title>
            <description>Participants received single oral dose of 200 mg favipiravir (Avigan 200 mg FT, Toyama-Japan) under fasting conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Favipiravir</title>
          <description>Time to reach maximum plasma concentration of favipiravir</description>
          <population>29 subjects were analysed and included in statistical analysis.</population>
          <units>hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.609" spread="0.343"/>
                    <measurement group_id="O2" value="0.733" spread="0.478"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>FAVICOVIR 200 MG FT (Atabay-Turkey)</title>
          <description>Participants received single oral dose of 200 favipiravir of Atabay-Turkey under fasting conditions.</description>
        </group>
        <group group_id="E2">
          <title>AVIGAN 200 MG FT (Toyama-Japan)</title>
          <description>Participants received single oral dose of 200 favipiravir of Toyama-Japan under fasting conditions.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Aydin Erenmemisoglu</name_or_title>
      <organization>Farmagen</organization>
      <phone>+90 532 551 0082</phone>
      <email>a.erenmemisoglu@farmagenarge.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/NCT04406194
org study id: NOV2020/1917
nct id: NCT04406194
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test
      product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at
      room temperature, in each period under fasting conditions with current pandemic precautions.
Favipiravir is a drug with a mechanism of action different from that of the existing
      influenza antiviral drugs and effective against all types and sub-types of human influenza A,
      B and C viruses in vitro, showing anti-viral activity against various influenza virus strains
      including avian and swine viruses. Favipiravir also has shown anti-viral activity even
      against amantadine, oseltamivir and zanamivir-resistant influenza viruses in vitro. The
      mechanism of action of favipiravir is the selective inhibition of RNA polymerase by
      favipiravir ribosyl triphosphate formed by cellular enzymes in the influenza virus leading to
      antiviral activity.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: AUC0-tlast of Favipiravir
time frame: 0 to 24 hours post-dose
description: Area under the concentration-time curve of favipiravir in plasma over the time interval from 0 to 24 hours
measure: Cmax of Favipiravir
time frame: 0 to 24 hours post-dose
description: Maximum plasma concentration of favipiravir
measure: AUC0-inf of Favipiravir
time frame: 0 to 24 hours post-dose
description: Area under the plasma concentration curve to infinite time of favipiravir
measure: Tmax of Favipiravir
time frame: 0 to 24 hours post-dose
description: Time to reach maximum plasma concentration of favipiravir
arm group label: FAVICOVIR then AVIGAN
arm group type: Experimental
description: Participants first received Favicovir 200 mg FT manufactured by Atabay in a fasting state. After a washout period of 48 hours, they then received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state.
arm group label: AVIGAN then FAVICOVIR
arm group type: Experimental
description: Participants first received Avigan FT200 mg manufactured by Toyama Chemical Industry Co.Ltd./Japan in a fasting state. After a washout period of 48 hours, they then received Favicovir 200 mg FT manufactured by Atabay in a fasting state.
intervention type: Drug
intervention name: FAVICOVIR 200 mg Film Tablet
description: FAVICOVIR 200 MG FT is containing 200 mg favipiravir manufactured by Atabay, Turkey.
arm group label: AVIGAN then FAVICOVIR
arm group label: FAVICOVIR then AVIGAN
other name: Favipiravir 200 MG FT
intervention type: Drug
intervention name: AVIGAN 200 mg Film Tablets
description: AVIGAN 200 mg FT is containing 200 mg favipiravir manufactured by Toyama, Japan.
arm group label: AVIGAN then FAVICOVIR
arm group label: FAVICOVIR then AVIGAN
other name: Favipiravir 200 mg FT
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Muradiye Nacak, MD,PhD
role: Principal Investigator
affiliation: Farmagen Ar-Ge Biyot. Ltd. Sti
facility: 
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Favipiravir
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 