<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20120624010104N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-24</date_registration>
      <primary_sponsor>Ahran Tejarat Pharmaceutical Company</primary_sponsor>
      <public_title>Ursodeoxycholic acid in cholelithiasis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of bioequivalency of Ursodeoxycholic acid capsule of Ahran Tejarat Company compared to Ursoflor® on 24 volunteers.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53692</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research.</study_design>
      <phase>Bioequivalence</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>Intervention 1: Each volunteer take 2 times the medication at least a week apart.                                                                       Intervention group: 1 -24 volunteers after their health is confirmed by the project doctor and signed the consent form is submitted to the project. 2 - In the fasting position 2 Ursodiol capsule 300 mg of Ahran Tejarat Company as a test product is prescribed with a glass of water (single Dose) 3 - At intervals of 0) before the administration of the drug), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 48, 72 hours after the administration of the drug, blood is taken from the volunteers. 4 -Isolated plasma transfer to the analysis laboratory to determine the amount of drug by HPLC method. Intervention 2: After at least a week apart:                                                            Intervention group: 1 -24 volunteers after their health is confirmed by the project doctor and signed the consent form is submitted to the project. 2 - In the fasting position 2 Ursoflor® capsule 300 mg of company So.Se.PHARM as reference is prescribed with a glass of water (single Dose) 3 - At intervals of 0) before the administration of the drug), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 48, 72 hours after the administration of the drug, blood is taken from the volunteers. 4 -Isolated plasma transfer to the analysis laboratory to determine the amount of drug by HPLC method.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Ansari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft bagh alavi</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616911319</zip>
        <telephone>+98 913 141 5342</telephone>
        <email>mansari@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Ansari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haft bagh alavi</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616911319</zip>
        <telephone>+98 913 141 5342</telephone>
        <email>mansari@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Complete clinical health
Age 18 to 60 years
Male volunteers</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Underlying diseases
Hypertension
Kidney
Liver and gastrointestinal diseases
Smoking and alcohol consumption
Chronic drug use
Temporary drug use less than 10 days after sampling</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Each volunteer take 2 times the medication at least a week apart.                                                                       Intervention group: 1 -24 volunteers after their health is confirmed by the project doctor and signed the consent form is submitted to the project. 2 - In the fasting position 2 Ursodiol capsule 300 mg of Ahran Tejarat Company as a test product is prescribed with a glass of water (single Dose) 3 - At intervals of 0) before the administration of the drug), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 48, 72 hours after the administration of the drug, blood is taken from the volunteers. 4 -Isolated plasma transfer to the analysis laboratory to determine the amount of drug by HPLC method.</i_keyword>
      <i_keyword>After at least a week apart:                                                            Intervention group: 1 -24 volunteers after their health is confirmed by the project doctor and signed the consent form is submitted to the project. 2 - In the fasting position 2 Ursoflor® capsule 300 mg of company So.Se.PHARM as reference is prescribed with a glass of water (single Dose) 3 - At intervals of 0) before the administration of the drug), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 48, 72 hours after the administration of the drug, blood is taken from the volunteers. 4 -Isolated plasma transfer to the analysis laboratory to determine the amount of drug by HPLC method.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determination of drug concentration in plasma. Timepoint: Blood sampling during 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 48, 72 hour after taking the drug. Method of measurement: UV-HPLC.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pharmacokinetic parameters. Timepoint: Immediately after the intervention. Method of measurement: Theoretically and using pharmacokinetic equations.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Ahran Tejarat</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-03</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Haft bagh alavi Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
