<?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>IRCT20200407046981N44</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-19</date_registration>
      <primary_sponsor>Vana Darou Gostar Pharmaceutical Company</primary_sponsor>
      <public_title>Study of absorption and elimination rate of Biperiden 4-mg extended-release tablets in comparison with Biperiden brand tablets (Akineton®)</public_title>
      <acronym></acronym>
      <scientific_title>Comparative bioequivalence study of the Biperiden 4-mg extended-release tablets manufactured by Vana Darou Gostar Pharmaceutical Company versus Akineton® (Desma Company)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66351</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: To randomly assign people in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are arranged irregularly. Each candidate will pick up an envelope after entering the study, and numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 and group B will receive intervention 2, and after the first period, the interventions of the both groups will change for the second period.</study_design>
      <phase>Bioequivalence</phase>
      <hc_freetext>Bioequivalence study.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:  In this group, volunteers are given a single oral dose of the Biperiden 4-mg extended-release tablets produced by Vana Darou Gostar Co. (Domestic). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 2. Intervention 2: Intervention group2: In this group, volunteers are given a single oral dose of Biperiden 4-mg extended-release tablets (Akineton®), produced by Desma Company (Brand). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 1.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatima Molavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165665811</zip>
        <telephone>+98 41 3336 2700</telephone>
        <email>Molavif@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Hamishehkar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165665811</zip>
        <telephone>+98 41 3336 7914</telephone>
        <email>Hamishehkar.hamed@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy male volunteers in the age range of 18-60 years old
The weight limit of each volunteer should be between 60 and 100 kg.
Body mass index should be between18-30
All volunteers must be non-smokers
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed
Candidates who have consented to the consent form</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Known hypersensitivity or idiosyncratic reaction to Biperiden or any ingredients
Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg
Taking any medicine during two week before dosing.
Any effects of renal, hepatic, cardiac, pulmonary or gastrointestinal dysfunction
Any history of tuberculosis, seizures, asthma, diabetes, insanity or glaucoma</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>Intervention group1:  In this group, volunteers are given a single oral dose of the Biperiden 4-mg extended-release tablets produced by Vana Darou Gostar Co. (Domestic). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 2.</i_keyword>
      <i_keyword>Intervention group2: In this group, volunteers are given a single oral dose of Biperiden 4-mg extended-release tablets (Akineton®), produced by Desma Company (Brand). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 1</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Peak Plasma Concentration (Cmax). Timepoint: 0 (before dosing), 1, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36 and 48 hours after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>AUC (Area Under the Concentration-Time Curve). Timepoint: 0 (before dosing), 1, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36 and 48 hours after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.</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>Vana Darou Gostar Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-03</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Science</contact_name>
        <contact_address>Third floor, central building No. 2, Golgasht street, Tabriz University of Medical Science, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
