<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/NCT04422028</url>
  </required_header>
  <id_info>
    <org_study_id>HP8824-01</org_study_id>
    <nct_id>NCT04422028</nct_id>
  </id_info>
  <brief_title>Bioavailability of Desogestrel 0.075 mg Tablets With Regards to Reference Product</brief_title>
  <official_title>Bioavailability of a Formulation of Desogestrel 0.075 mg Coated Tablets With Regards to the Marketed Reference Product</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laboratorios Andromaco S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laboratorios Andromaco S.A.</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 Pivotal study investigated the bioavailability in women of 2 tablet formulations&#xD;
      containing Desogestrel 0.075 mg. The Pivotal study was performed at a single site with 30&#xD;
      subjects. Participants took 2 tablets of the test product and reference product in 2 periods&#xD;
      and 2 sequences (either test after reference or reference after test). There was a washout of&#xD;
      14 days between each study period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the study is to investigate the relative bioavailability of&#xD;
      Desogestrel of 2 tablet formulations with Desogestrel 0.075 mg to demonstrate bioequivalence&#xD;
      of both formulations in terms of rate and extent of absorption:&#xD;
&#xD;
        -  Test Product: Product manufactured by Laboratorios Andrómaco S.A.&#xD;
&#xD;
        -  Reference Product: Cerazette [Trademark], product of Merck Sharp and Dohme Ltda.,&#xD;
           Brasil.&#xD;
&#xD;
      The 90% confidence intervals for the intra-subject coefficient of variation (Test versus&#xD;
      Reference Product) for the main pharmacokinetic parameters area under the plasma&#xD;
      concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours&#xD;
      (AUC0-72), and maximum plasma concentration (Cmax) for total metabolite etonogestrel was&#xD;
      determined.&#xD;
&#xD;
      Participants were confined in the study site for approximately 36 hours during each study&#xD;
      period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic&#xD;
      (PK) blood samples were obtained. 16 blood samples were taken up to 24 hours after the&#xD;
      administration in each period. Participants returned to the site to provide additional blood&#xD;
      samples at 48 h, and 72 h postdose.&#xD;
&#xD;
      The washout period between the two study periods was 14 days. The samples from each&#xD;
      participant were analyzed with 2 methods of highperformance liquid chromatography-tandem mass&#xD;
      spectrometry bioanalytical assays to quantify total Dienogest and Ethinyl estradiol in&#xD;
      plasma.&#xD;
&#xD;
      The safety objective was to evaluate the tolerability of both formulations in women by&#xD;
      collecting adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2020</start_date>
  <completion_date type="Actual">January 28, 2020</completion_date>
  <primary_completion_date type="Actual">January 11, 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total etonogestrel: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72).</measure>
    <time_frame>From tablet intake and up to 72 hours after tablet intake.</time_frame>
    <description>19 samples up to 72 hours will be taken after the administration in each period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total etonogestrel: area under the plasma concentration-time curve from 0 to time t (AUC0-t)</measure>
    <time_frame>From tablet intake and up to 72 hours after tablet intake.</time_frame>
    <description>19 samples up to 72 hours will be taken after the administration in each period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total etonogestrel: Maximum plasma concentration (Cmax)</measure>
    <time_frame>From tablet intake and up to 72 hours after tablet intake</time_frame>
    <description>19 samples up to 72 hours will be taken after the administration in each period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total etonogestrel: Time to achieve maximum plasma concentration (tmax)</measure>
    <time_frame>From tablet intake and up to 72 hours after tablet intake</time_frame>
    <description>19 samples up to 72 hours will be taken after the administration in each period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Bioequivalence</condition>
  <arm_group>
    <arm_group_label>Desogestrel Test Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received two tablets of the test formulation containing Desogestrel 0.075 mg. The tablets were taken with water and in a fasting condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Desogestrel Reference Product</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received two tablets of the marketed reference formulation containing Desogestrel 0.075 mg. The tablets were taken with water and in a fasting condition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desogestrel 0.075 MG</intervention_name>
    <description>Test Drug</description>
    <arm_group_label>Desogestrel Test Product</arm_group_label>
    <other_name>Investigational Medicinal Product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desogestrel 0.075 MG</intervention_name>
    <description>Reference Product</description>
    <arm_group_label>Desogestrel Reference Product</arm_group_label>
    <other_name>Cerazette (Trademark)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-pregnant and non-breastfeeding women&#xD;
&#xD;
          -  Women of childbearing age with an acceptable form of contraception during the study&#xD;
&#xD;
          -  18 to 55 years old inclusive; BMI greater than or equal to 18.51 and less than or&#xD;
             equal to 29.99&#xD;
&#xD;
          -  Non-smoking or smoke only 3 cigarettes every 7 days&#xD;
&#xD;
          -  With results of laboratory tests, electrocardiogram and chest radiography in normal&#xD;
             and / or negative or abnormal ranges but without clinical relevance and declared&#xD;
             suitable for study by the doctor after the physical examination&#xD;
&#xD;
          -  Capable to understand the Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Study site staff or sponsor staff or family members&#xD;
&#xD;
          -  With history of drug and/or alcohol abuse&#xD;
&#xD;
          -  Smokers more tan 3 cigarettes every 7 days&#xD;
&#xD;
          -  Vitamin supplements intake 7 days prior to the administration of the medications under&#xD;
             study&#xD;
&#xD;
          -  Any recent change in eating habits or physical exercise&#xD;
&#xD;
          -  Using of a pharmacological therapy (except over the counter medication use 7 days&#xD;
             prior to the study)&#xD;
&#xD;
          -  Hypersensitivity to the study drug or to other chemically related compounds, history&#xD;
             of serious adverse reactions or hypersensitivity to any medication&#xD;
&#xD;
          -  Use, during the 28 days prior to the start of the study, of medications known to alter&#xD;
             liver enzyme activity&#xD;
&#xD;
          -  Consumption of beverages or food containing grapefruit or pink grapefruit, within 7&#xD;
             days prior to each administration of the study medication and consumption of alcohol,&#xD;
             caffeine or beverages or foods containing xanthines 24 hours before each&#xD;
             administration of the study medication until the last sample of each period&#xD;
&#xD;
          -  History of any significant cardiovascular disease&#xD;
&#xD;
          -  Acute disease that generates significant physiological changes from the time of&#xD;
             selection until the end of the study&#xD;
&#xD;
          -  HIV, Hepatitis B and/or C positive&#xD;
&#xD;
          -  Presence or history of thrombophlebitis, thrombosis or thromboembolic disorders, deep&#xD;
             vein thrombosis, pulmonary embolism or known coagulopathy.&#xD;
&#xD;
          -  Donation or loss of a significant volume (more than 100 mL) of blood or plasma or&#xD;
             platelets during the 3 months prior to the start of the study&#xD;
&#xD;
          -  Subjects who have participated in any type of clinical study during the 3 months prior&#xD;
             to the start of the study&#xD;
&#xD;
          -  History of any gastrointestinal surgery that could affect drug absorption&#xD;
&#xD;
          -  Presence of fainting history or fear to blood collection&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Study Director Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Laboratorios Andromaco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Innolab</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Desogestrel</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/NCT04422028
org study id: HP8824-01
nct id: NCT04422028
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This Pivotal study investigated the bioavailability in women of 2 tablet formulations
      containing Desogestrel 0.075 mg. The Pivotal study was performed at a single site with 30
      subjects. Participants took 2 tablets of the test product and reference product in 2 periods
      and 2 sequences (either test after reference or reference after test). There was a washout of
      14 days between each study period.
The primary objective of the study is to investigate the relative bioavailability of
      Desogestrel of 2 tablet formulations with Desogestrel 0.075 mg to demonstrate bioequivalence
      of both formulations in terms of rate and extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Andrómaco S.A.

        -  Reference Product: Cerazette [Trademark], product of Merck Sharp and Dohme Ltda.,
           Brasil.

      The 90% confidence intervals for the intra-subject coefficient of variation (Test versus
      Reference Product) for the main pharmacokinetic parameters area under the plasma
      concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours
      (AUC0-72), and maximum plasma concentration (Cmax) for total metabolite etonogestrel was
      determined.

      Participants were confined in the study site for approximately 36 hours during each study
      period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic
      (PK) blood samples were obtained. 16 blood samples were taken up to 24 hours after the
      administration in each period. Participants returned to the site to provide additional blood
      samples at 48 h, and 72 h postdose.

      The washout period between the two study periods was 14 days. The samples from each
      participant were analyzed with 2 methods of highperformance liquid chromatography-tandem mass
      spectrometry bioanalytical assays to quantify total Dienogest and Ethinyl estradiol in
      plasma.

      The safety objective was to evaluate the tolerability of both formulations in women by
      collecting adverse events.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Total etonogestrel: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72).
time frame: From tablet intake and up to 72 hours after tablet intake.
description: 19 samples up to 72 hours will be taken after the administration in each period.
measure: Total etonogestrel: area under the plasma concentration-time curve from 0 to time t (AUC0-t)
time frame: From tablet intake and up to 72 hours after tablet intake.
description: 19 samples up to 72 hours will be taken after the administration in each period.
measure: Total etonogestrel: Maximum plasma concentration (Cmax)
time frame: From tablet intake and up to 72 hours after tablet intake
description: 19 samples up to 72 hours will be taken after the administration in each period.
measure: Total etonogestrel: Time to achieve maximum plasma concentration (tmax)
time frame: From tablet intake and up to 72 hours after tablet intake
description: 19 samples up to 72 hours will be taken after the administration in each period.
arm group label: Desogestrel Test Product
arm group type: Experimental
description: Participants received two tablets of the test formulation containing Desogestrel 0.075 mg. The tablets were taken with water and in a fasting condition.
arm group label: Desogestrel Reference Product
arm group type: Active Comparator
description: Participants received two tablets of the marketed reference formulation containing Desogestrel 0.075 mg. The tablets were taken with water and in a fasting condition.
intervention type: Drug
intervention name: Desogestrel 0.075 MG
description: Test Drug
arm group label: Desogestrel Test Product
other name: Investigational Medicinal Product
intervention type: Drug
intervention name: Desogestrel 0.075 MG
description: Reference Product
arm group label: Desogestrel Reference Product
other name: Cerazette (Trademark)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Study Director Study Director
role: Study Director
affiliation: Laboratorios Andromaco
facility: 
country: Chile
responsible party type: Sponsor
mesh term: Desogestrel
sharing ipd: No