<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/NCT04494191</url>
  </required_header>
  <id_info>
    <org_study_id>GRC/1/18/751</org_study_id>
    <nct_id>NCT04494191</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)</brief_title>
  <official_title>Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genuine Research Center, Egypt</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bio Med for Pharmaceuticals Industries (BIOMED), Egypt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Genuine Research Center, Egypt</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>
      An open label randomized, single dose, two-way crossover bioequivalence study to determine&#xD;
      the bioequivalence of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals&#xD;
      Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic&#xD;
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the&#xD;
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for&#xD;
      untransformed data of Ke, tmax and t1/2e.&#xD;
&#xD;
      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,&#xD;
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.&#xD;
&#xD;
      A comprehensive final report will be issued upon the completion of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">February 27, 2019</completion_date>
  <primary_completion_date type="Actual">December 19, 2018</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>Cmax</measure>
    <time_frame>Up to 48 hours post dose in each treatment period</time_frame>
    <description>Maximal measured plasma concentration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of the maximum plasma concentration (Tmax)</measure>
    <time_frame>Up to 48 hours post dose in each treatment period</time_frame>
    <description>The amount of time that a drug is present at the maximum concentration in serum</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>T test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test drug (AphroFemine) 1 tablet contains 100 mg Flibanserin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B reference</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reference drug (Addyi) 1 tablet contains 100 mg Flibanserin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flibanserin 100Mg Tab</intervention_name>
    <description>One tablet contains 100 mg Flibanserin</description>
    <arm_group_label>T test</arm_group_label>
    <other_name>AphroFemine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flibanserin 100 MG [Addyi]</intervention_name>
    <description>One tablet contains 100 mg Flibanserin</description>
    <arm_group_label>B reference</arm_group_label>
    <other_name>Addyi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy females, age 18 to 55 years, inclusive.&#xD;
&#xD;
          -  Body weight within 15% of normal range according to the accepted normal values for&#xD;
             body mass index (BMI).&#xD;
&#xD;
          -  Medical demographics without evidence of clinically significant deviation from normal&#xD;
             medical condition.&#xD;
&#xD;
          -  Results of clinical laboratory test are within the normal range or with a deviation&#xD;
             that is not considered clinically significant by principal investigator.&#xD;
&#xD;
          -  Subject does not have allergy to the drugs under investigation.&#xD;
&#xD;
          -  Females should be on a suitable birth control method.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Subjects with known allergy to the products tested.&#xD;
&#xD;
          -  Subjects whose values of BMI were outside the accepted normal ranges.&#xD;
&#xD;
          -  Female subjects who were pregnant or nursing.&#xD;
&#xD;
          -  Medical demographics with evidence of clinically significant deviation from normal&#xD;
             medical condition.&#xD;
&#xD;
          -  Results of laboratory tests which are clinically significant.&#xD;
&#xD;
          -  Acute infection within one week preceding first study drug administration.&#xD;
&#xD;
          -  History of drug or alcohol abuse.&#xD;
&#xD;
          -  Subject does not agree not to take any prescription or non-prescription drugs within&#xD;
             two weeks before first study drug administration and until the end of the study.&#xD;
&#xD;
          -  Subject is on a special diet (for example subject is vegetarian).&#xD;
&#xD;
          -  Subject does not agree not to consume any beverages or foods containing&#xD;
             methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to&#xD;
             the study administration of either study period until donating the last sample in each&#xD;
             respective period.&#xD;
&#xD;
          -  Subject does not agree not to consume any beverages or foods containing grapefruit 7&#xD;
             days prior to first study drug administration until the end of the study.&#xD;
&#xD;
          -  Subject has a history of severe diseases which have direct impact on the study.&#xD;
&#xD;
          -  Participation in a bioequivalence study or in a clinical study within the last 6 weeks&#xD;
             before first study drug administration.&#xD;
&#xD;
          -  Subject intends to be hospitalized within 3 months after first study drug&#xD;
             administration.&#xD;
&#xD;
          -  Subjects who, through completion of this study, would have donated more than 500 ml of&#xD;
             blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120&#xD;
             days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Healthy non pregnant females, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Elshafeey, Ph.D. Pharma</last_name>
    <role>Study Director</role>
    <affiliation>Genuine Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Genuine Research Center GRC</name>
      <address>
        <city>Cairo</city>
        <zip>11511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.ema.europa.eu/ema</url>
    <description>Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) The European Agency for the Evaluation of Medicinal Products (EMEA) May 1997</description>
  </link>
  <link>
    <url>http://www.ema.europa.eu/ema</url>
    <description>Note for Guidance on Clinical Safety Data Management; Definitions And Standards for Expedited Reporting (CPMP/ICH/377/95) The European Agency for the Evaluation of Medicinal Products (EMEA) June 1995.</description>
  </link>
  <reference>
    <citation>Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353. Erratum In: J Pharmacokinet Pharmacodyn. 2002 Feb;29(1):101.</citation>
    <PMID>11381568</PMID>
  </reference>
  <reference>
    <citation>Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.</citation>
    <PMID>2004861</PMID>
  </reference>
  <reference>
    <citation>Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.</citation>
    <PMID>3450848</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04494191
org study id: GRC/1/18/751
nct id: NCT04494191
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An open label randomized, single dose, two-way crossover bioequivalence study to determine
      the bioequivalence of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals
      Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)
Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax
time frame: Up to 48 hours post dose in each treatment period
description: Maximal measured plasma concentration
measure: Time of the maximum plasma concentration (Tmax)
time frame: Up to 48 hours post dose in each treatment period
description: The amount of time that a drug is present at the maximum concentration in serum
arm group label: T test
arm group type: Experimental
description: Test drug (AphroFemine) 1 tablet contains 100 mg Flibanserin
arm group label: B reference
arm group type: Active Comparator
description: Reference drug (Addyi) 1 tablet contains 100 mg Flibanserin
intervention type: Drug
intervention name: Flibanserin 100Mg Tab
description: One tablet contains 100 mg Flibanserin
arm group label: T test
other name: AphroFemine
intervention type: Drug
intervention name: Flibanserin 100 MG [Addyi]
description: One tablet contains 100 mg Flibanserin
arm group label: B reference
other name: Addyi
criteria: 
gender: Female
gender based: Yes
gender description: Healthy non pregnant females, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed Elshafeey, Ph.D. Pharma
role: Study Director
affiliation: Genuine Research Center
facility: 
country: Egypt
url: http://www.ema.europa.eu/ema
description: Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) The European Agency for the Evaluation of Medicinal Products (EMEA) May 1997
url: http://www.ema.europa.eu/ema
description: Note for Guidance on Clinical Safety Data Management; Definitions And Standards for Expedited Reporting (CPMP/ICH/377/95) The European Agency for the Evaluation of Medicinal Products (EMEA) June 1995.
citation: Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353. Erratum In: J Pharmacokinet Pharmacodyn. 2002 Feb;29(1):101.
PMID: 11381568
citation: Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.
PMID: 2004861
citation: Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
PMID: 3450848
responsible party type: Sponsor
sharing ipd: No