<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/NCT02185833</url>
  </required_header>
  <id_info>
    <org_study_id>DIRI502/PRO-00</org_study_id>
    <nct_id>NCT02185833</nct_id>
  </id_info>
  <brief_title>Bioequivalence Pilot Study of Dirithromycin of (Abdi İbrahim İlaç San.Ve.Tic.A.Ş,Turkey) in Healthy Subjects Under Fasting Condition</brief_title>
  <official_title>Comparative, Randomized, Two -Period, Two-treatment, Two -Sequence, Open Label, Crossover Bioequivalence Pilot Study of Dirithromycin 500 mg Enteric Coated Tablet (One Tablet) of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) Versus Dynabac 250 mg Enteric Coated Tablet (Two Tablets) of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) in Healthy Subjects Under Fasting Conditions.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pharmaceutical Research Unit, Jordan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abdi Ibrahim Ilac San. ve Tic A.S.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pharmaceutical Research Unit, Jordan</source>
  <brief_summary>
    <textblock>
      To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE&#xD;
      products by measurement of Plasma concentrations of Erythromycylamine and calculation of the&#xD;
      bioequivalence parameters from those measurements followed by ANOVA and 90% confidence&#xD;
      interval statistical evaluation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label, randomized, two-treatments, two-periods, two-sequences, crossover&#xD;
      bioequivalence pilot study with a washout period of at least 14 days between doses. Healthy,&#xD;
      mixed skin Arab &amp; Mediterranean Subjects ages between 18 and 50 years, body-mass index 18.5&#xD;
      to 30.0 kg/m2 inclusive (minimum of 50 kg weight), non-smokers or light smokers (smokers of&#xD;
      not more than 10 cigarettes per day).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax Ratio</measure>
    <time_frame>pre-dosing and at 1.00, 1.50, 2.00, 2.25, 2.50, 2.75 ,3.00 ,3.25, 3.50 ,3.75 ,4.00 ,4.50 ,5.00 ,5.50 ,6.00 ,8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00hours after dosing</time_frame>
    <description>The 90% confidence interval for this measure lies within an acceptance range of 80.00%-125.00% based on Erythromycylamine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC Ratio</measure>
    <time_frame>pre-dosing and at 1.00, 1.50, 2.00, 2.25, 2.50, 2.75 ,3.00 ,3.25, 3.50 ,3.75 ,4.00 ,4.50 ,5.00 ,5.50 ,6.00 ,8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00hours after dosing</time_frame>
    <description>The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00%based on Erythromycylamine.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>DIRITHROMYCIN 500 MG ENTERIC COATED TABLET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DIRITHROMYCIN 500 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey one tablet, once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DYNABAC 250 MG ENTERIC COATED TABLET</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DYNABAC 250 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey, two tablets, once</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DIRITHROMYCIN 500 MG ENTERIC COATED TABLET</intervention_name>
    <arm_group_label>DIRITHROMYCIN 500 MG ENTERIC COATED TABLET</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DYNABAC 250 MG ENTERIC COATED TABLET</intervention_name>
    <arm_group_label>DYNABAC 250 MG ENTERIC COATED TABLET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy subjects.&#xD;
&#xD;
          2. Ethnic Group: Arab &amp; Mediterranean.&#xD;
&#xD;
          3. Race: Mixed skin (white &amp; black skin people).&#xD;
&#xD;
          4. Age 18-50 years.&#xD;
&#xD;
          5. Body-mass index 18.5 to 30.0 kg/m2 inclusive. (minimum of 50 kg weight)&#xD;
&#xD;
          6. Subject is available for the whole study period and gave written informed consent.&#xD;
&#xD;
          7. Normal Physical examination.&#xD;
&#xD;
          8. Vital signs within normal ranges.&#xD;
&#xD;
          9. All laboratory screening results within the normal range, or being assessed as&#xD;
             clinically Non-significant by the attending physician.&#xD;
&#xD;
         10. Normal Kidney &amp; Liver functions test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women of childbearing potential who don't use any contraceptive method, pregnant&#xD;
             and/or lactating women.&#xD;
&#xD;
          2. Ethnic Group (Non- Arab &amp;/ or Non- Mediterranean)&#xD;
&#xD;
          3. History of severe allergy or allergic reactions to study drug or related drugs or&#xD;
             heparin&#xD;
&#xD;
          4. Known history or presence of food allergies, or any condition known to interfere with&#xD;
             the absorption, distribution, metabolism or excretion of drugs&#xD;
&#xD;
          5. History of serious illness that can impact fate of drugs&#xD;
&#xD;
          6. Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine,&#xD;
             musculoskeletal, neurological, hematological, liver or kidney disease.&#xD;
&#xD;
          7. Clinically significant illness 4 weeks before study Period I&#xD;
&#xD;
          8. Mental disease.&#xD;
&#xD;
          9. Smoking of more than 10 cigarettes per day&#xD;
&#xD;
         10. Intake of Alcohol, caffeine, or xanthine beverages 16 hrs before each study drug&#xD;
             administration.&#xD;
&#xD;
         11. Regular use of medication.&#xD;
&#xD;
         12. Having taken medication that could affect the investigated drug product: a) Regular&#xD;
             consumption of drugs during the two weeks prior to study initiation day, b)&#xD;
             consumption of enzyme stimulating or inhibiting drugs (e.g. Barbiturates,&#xD;
             Carbamazepine, Phenytoin, Amphetamine, Benzodiazepine, cannabinoid, cocaine, opiates,&#xD;
             phencyclidine and methadone) during one month before the study initiation.&#xD;
&#xD;
         13. Presence of any significant physical or organ abnormality&#xD;
&#xD;
         14. Donation of 1) at least 400 ml of blood within 60 days, or 2) more than 150 ml of&#xD;
             blood within 30 days, or 3) more than 100 ml blood plasma or platelets within 14 days&#xD;
             before study Period I&#xD;
&#xD;
         15. Participation in another bioequivalence study and/or Clinical trials within 80 days&#xD;
             prior to the start of this study Period I&#xD;
&#xD;
         16. Following a special diet (e.g. vegetarian) or dieting one month before the study&#xD;
             initiation.&#xD;
&#xD;
         17. Prior history of hypersensitivity to dirithromycin, erythromycin, or other macrolide&#xD;
             antibiotics&#xD;
&#xD;
         18. Subjects with seizures or prior history of seizures&#xD;
&#xD;
         19. Any significant clinical abnormality including HBsAg, HCV, and / or HIV.&#xD;
&#xD;
         20. Consumption of grapefruit or grapefruit containing products within 7 days of drug&#xD;
             administration&#xD;
&#xD;
         21. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose&#xD;
             of the study medication.&#xD;
&#xD;
         22. Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent&#xD;
             significant change in dietary or exercise habits.&#xD;
&#xD;
         23. Abnormal Vital Signs.&#xD;
&#xD;
         24. Abnormal Kidney and/or Liver functions test.&#xD;
&#xD;
         25. Vomiting, Diarrhea on admission&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rana T Bustami, Phd.pharmacy</last_name>
    <role>Principal Investigator</role>
    <affiliation>PRU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit</name>
      <address>
        <city>Amman</city>
        <zip>11941</zip>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>July 6, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fasting condition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dirithromycin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02185833
org study id: DIRI502/PRO-00
nct id: NCT02185833
lead sponsor: 
collaborator: 
To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE
      products by measurement of Plasma concentrations of Erythromycylamine and calculation of the
      bioequivalence parameters from those measurements followed by ANOVA and 90% confidence
      interval statistical evaluation.
An open-label, randomized, two-treatments, two-periods, two-sequences, crossover
      bioequivalence pilot study with a washout period of at least 14 days between doses. Healthy,
      mixed skin Arab & Mediterranean Subjects ages between 18 and 50 years, body-mass index 18.5
      to 30.0 kg/m2 inclusive (minimum of 50 kg weight), non-smokers or light smokers (smokers of
      not more than 10 cigarettes per day).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax Ratio
time frame: pre-dosing and at 1.00, 1.50, 2.00, 2.25, 2.50, 2.75 ,3.00 ,3.25, 3.50 ,3.75 ,4.00 ,4.50 ,5.00 ,5.50 ,6.00 ,8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00hours after dosing
description: The 90% confidence interval for this measure lies within an acceptance range of 80.00%-125.00% based on Erythromycylamine.
measure: AUC Ratio
time frame: pre-dosing and at 1.00, 1.50, 2.00, 2.25, 2.50, 2.75 ,3.00 ,3.25, 3.50 ,3.75 ,4.00 ,4.50 ,5.00 ,5.50 ,6.00 ,8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00hours after dosing
description: The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00%based on Erythromycylamine.
arm group label: DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
arm group type: Experimental
description: DIRITHROMYCIN 500 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey one tablet, once
arm group label: DYNABAC 250 MG ENTERIC COATED TABLET
arm group type: Active Comparator
description: DYNABAC 250 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey, two tablets, once
intervention type: Drug
intervention name: DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
arm group label: DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
intervention type: Drug
intervention name: DYNABAC 250 MG ENTERIC COATED TABLET
arm group label: DYNABAC 250 MG ENTERIC COATED TABLET
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rana T Bustami, Phd.pharmacy
role: Principal Investigator
affiliation: PRU
facility: 
country: Jordan
responsible party type: Sponsor
mesh term: Disease
mesh term: Dirithromycin