<?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>IRCT20220111053692N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-07</date_registration>
      <primary_sponsor>Iran Hormone pharmaceutical Co.</primary_sponsor>
      <public_title>Bioequivalence study of valacyclovir 1000 mg tablet</public_title>
      <acronym></acronym>
      <scientific_title>Bioequivalence study of valacyclovir 1000 mg tablet (Iran Hormone) versus VALTREX ® 1000 mg (GlaxoSmithKline) Tablet in healthy volunteers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63110</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: A group of 24 people is then selected as the sample size using Excel software in a balanced way, one of the AB or BA sequences is randomly assigned to each candidate. They are then randomly divided into two groups of 12 and given to one group of test tablets and to the other group of reference tablets, Blinding description: This study is a Double-blind (participant) clinical trial. Valacyclovir and valterex tablets are removed from the package by the administrator and placed in similar and coded cans.</study_design>
      <phase>Bioequivalence</phase>
      <hc_freetext>Bioequivalence study of valacyclovir 1000 mg tablet (Iran Hormone) versus VALTREX ® 1000 mg (GlaxoSmithKline) Tablet in healthy volunteers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receives one tablet of test drug (valaciclovir 1000 mg from Iran Hormone Pharmaceutical Company). Blood samples were taken from the volunteers for 24 hours at the mentioned times after drug administration and the drug concentration in plasma samples was measured by liquid chromatography with UV detector. Intervention 2: Control group: Receives one reference medicine tablet (Valtrex 1000 mg from GlaxoSmithKline). Blood samples were taken from the volunteers for 24 hours at the mentioned times after drug administration and the drug concentration in plasma samples was measured by liquid chromatography with UV detector.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bardia Jamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1,No. 1,Crot Building, Jahan mehr Street,Shahid Gomnam Street,Fatemi Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1431653941</zip>
        <telephone>+98 21 8897 4707</telephone>
        <email>info@tampouya.com</email>
        <affiliation>Tam Pouya Consulting &amp; Research Company</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bardia jamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, No. 1, Crot Building, Jahan-mehr Street, Shahid Gomnam Street, Fatemi Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1431653941</zip>
        <telephone>+98 21 8897 4707</telephone>
        <email>info@tampouya.com</email>
        <affiliation>Tam Pouya Consulting &amp; Research Company</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18 to 55 years old
Weight in range of 10 % proper body weight
All volunteers should be in a good health condition on the basis of medical history, physical examination, routine blood test.
and possessing negative test for hepatitis B surface antigen (HBs-Ag), antihepatitis-C antibody (anti-HCV), and anti-HIV.
just man</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Volunteers with hypersensitivity to valacyclovir were excluded.
those with known history of drug abuse. alcohol consumer or cigarette smokers.
Taking medications that have drug interactions with valacyclovir until one month before studying.
disinclination to take the test
Blood donation or blood loss of more than 200 ml in the past month</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Receives one tablet of test drug (valaciclovir 1000 mg from Iran Hormone Pharmaceutical Company). Blood samples were taken from the volunteers for 24 hours at the mentioned times after drug administration and the drug concentration in plasma samples was measured by liquid chromatography with UV detector.</i_keyword>
      <i_keyword>Control group: Receives one reference medicine tablet (Valtrex 1000 mg from GlaxoSmithKline). Blood samples were taken from the volunteers for 24 hours at the mentioned times after drug administration and the drug concentration in plasma samples was measured by liquid chromatography with UV detector</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Drug concentration in plasma samples. Timepoint: In times 0, 0/25, 0/5, 0/75, 1, 1/25, 1/5, 1/75, 2, 2/5, 3, 4, 6, 8, 10, 24, 30 Hours after the start of the intervention. Method of measurement: chromatography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Iran Hormone pharmaceutical Co.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-25</approval_date>
        <contact_name>Research Ethics Committees of The Institute of Pharmaceutical Sciences -Tehran University of Medical</contact_name>
        <contact_address>Research Institute of Pharmaceutical Sciences, second floor of the old building, Faculty of Pharmacy, Enqelab Square, 16 Azar St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
