<?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>IRCT20230222057495N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-05</date_registration>
      <primary_sponsor>Aria Pharmaceutical Company</primary_sponsor>
      <public_title>In vivo study of famotidine tablet 40 mg</public_title>
      <acronym>IVSF</acronym>
      <scientific_title>In vivo study of famotidine tablet 40 mg, iranian product compare to the brand one on healthy volunteers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68989</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Used, Assignment: Crossover, Purpose: Other.</study_design>
      <phase>Bioequivalence</phase>
      <hc_freetext>---.</hc_freetext>
      <i_freetext>Intervention group: The study consists of two phases (taking a famotidine 40 mg tablet orally at each study time, for a total of 2 times) with a one-week washout period (when the drug is completely out of your blood). Each stage lasts for 12 hours. You must fast for 10 hours before the start of each stage. On the morning of the study, you must be present at the place of the study at 7:00 a.m. to have an angiocath installed on your arm and for 12 hours. It will remain on your hand. 5 ml of blood before taking the medicine and during sampling times in minutes: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300, 360, 420, 600, 720 will be taken from you (15 times in total). With a gap of one week after receiving the first drug, the candidates must go to receive another drug and all these steps will be repeated. The total duration of participation of the candidates in both stages of this study will be a total of 24 hours, during which the candidates are covered by Pasargad insurance and financially supported by Aria Pharmaceutical Company (as the employer in this study). In the first stage of the study, you will be randomly assigned to one of the following two groups: group one consumes formula A and group two consumes formula B. Formulas A and B are products in the form of tablets produced in Belarus and Iran..</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Monireh Jalalipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 419, Imam Khomeini Blvd., Azadegan Square, Alborz, Karaj, Mahdasht</address>
        <city>Karaj Mahdasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3188913179</zip>
        <telephone>+98 26 3731 8748</telephone>
        <email>info@naplab.ir</email>
        <affiliation>Nikazma Pars Alborz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Monireh Jalalipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 419, Imam Khomeini Blvd., Azadegan Square, Alborz, Karaj, Mahdasht</address>
        <city>Karaj Mahdasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3188913179</zip>
        <telephone>+98 26 3731 8748</telephone>
        <email>info@naplab.ir</email>
        <affiliation>Nikazma Pars Alborz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 to 50 years
Non smoking
BMI below 30 kg/m2</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Blood pressure below 90/60 or more than 140/90 mmHg
Smoking person (more than 10 /day)
Using any kinds of medicine, alcohol or opioids during 2 weeks before starting the study</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The study consists of two phases (taking a famotidine 40 mg tablet orally at each study time, for a total of 2 times) with a one-week washout period (when the drug is completely out of your blood). Each stage lasts for 12 hours. You must fast for 10 hours before the start of each stage. On the morning of the study, you must be present at the place of the study at 7:00 a.m. to have an angiocath installed on your arm and for 12 hours. It will remain on your hand. 5 ml of blood before taking the medicine and during sampling times in minutes: 20, 40, 60, 80, 100, 120, 150, 180, 240, 300, 360, 420, 600, 720 will be taken from you (15 times in total). With a gap of one week after receiving the first drug, the candidates must go to receive another drug and all these steps will be repeated. The total duration of participation of the candidates in both stages of this study will be a total of 24 hours, during which the candidates are covered by Pasargad insurance and financially supported by Aria Pharmaceutical Company (as the employer in this study). In the first stage of the study, you will be randomly assigned to one of the following two groups: group one consumes formula A and group two consumes formula B. Formulas A and B are products in the form of tablets produced in Belarus and Iran.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Famotidine plasma concentrations. Timepoint: 0, 20 ، 40 ، 60 ، 80 ، 100 ، 120 ، 150 ، 180 ، 240 ، 300 ، 360، 420، 600 ، 720 minutes after dose. Method of measurement: By HPLC- UV analytical instrument.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>. Timepoint: . Method of measurement: .</sec_outcome>
      <sec_outcome>. Timepoint: . Method of measurement: .</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>Aria Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-01</approval_date>
        <contact_name>Pharmacetical science Institude of Tehran university of medical science</contact_name>
        <contact_address>Poursina Ave, Tehran University of Medical Science, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
