<?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>IRCT20240804062647N81</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-11-07</date_registration>
      <primary_sponsor>Abidi Pharmaceutical Company</primary_sponsor>
      <public_title>Bioequivalence Study of Rimegepant 75 mg Orally Disintegrating Tablet (RIPEVA®) by Dr. Abidi Pharmaceutical Company</public_title>
      <acronym></acronym>
      <scientific_title>In-vivo Bioequivalence Study of Rimegepant 75 mg Orally Disintegrating Tablet (RIPEVA®) of The Test Drug manufactured by Dr. Abidi Pharmaceutical Company in Compared with The Reference Drug NURTEC® 75 mg</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93615</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Initially, volunteers are screened according to the study inclusion and exclusion criteria, and 24 eligible volunteers are selected. Randomization is performed using Microsoft Excel and the RAND() function. For this purpose, random values are generated for numbers 1 to 24, and the order of these numbers is randomly determined based on the generated values. Each volunteer is then assigned a unique number according to the randomization list and receives an identification card containing the assigned number. During the first study period, volunteers assigned even numbers receive the reference drug (R), while those assigned odd numbers receive the test drug (T). In the second period, the treatments are switched in a crossover manner, so that volunteers who received the reference drug in the first period receive the test drug in the second period, and vice versa. The final randomization list is kept unchanged after preparation and used for study implementation, Blinding description: This study is a single-blind (participant) clinical trial Rimegepant 75 mg Orally Disintegrating Tablet (RIPEVA®) of The Test Drug manufactured by Dr. Abidi Pharmaceutical Company and the original brand are removed from their packaging by the operator and placed in identical, coded cans. Volunteers are unaware of the type of drug or test they are receiving.</study_design>
      <phase>Bioequivalence</phase>
      <hc_freetext>This study is performed on healthy volunteers..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Volunteers in this group will receive a single 75 mg dose of Rimegepant orally disintegrating tablet (RIPEVA), manufactured by Dr. Abidi Pharmaceutical Company (Test product), during the first study period. Following a one-week washout period, they will receive a single 75 mg dose of NURTEC ODT (Reference product) during the second study period. Intervention 2: Intervention group 2: Volunteers in this group will receive a single 75 mg dose of NURTEC ODT (Reference product) during the first study period. Following a one-week washout period, they will receive a single 75 mg dose of Rimegepant orally disintegrating tablet (RIPEVA), manufactured by Dr. Abidi Pharmaceutical Company (Test product), during the second study period.</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 These data are as secure between researchers and related industries.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Massoud Amanlou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy, 16 Azar Avenue, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 6695 9067</telephone>
        <email>amanlou@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Massoud Amanlou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy, 16 Azar Avenue, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 6695 9067</telephone>
        <email>amanlou@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>General health (liver, heart, kidney) of volunteers
Informed consent form
Body mass index range (18-30)
Age between18-55</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Smoking
Pregnancy
Having a hypersensitivity to the drug
Alcohol consumption</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 group 1: Volunteers in this group will receive a single 75 mg dose of Rimegepant orally disintegrating tablet (RIPEVA), manufactured by Dr. Abidi Pharmaceutical Company (Test product), during the first study period. Following a one-week washout period, they will receive a single 75 mg dose of NURTEC ODT (Reference product) during the second study period.</i_keyword>
      <i_keyword>Intervention group 2: Volunteers in this group will receive a single 75 mg dose of NURTEC ODT (Reference product) during the first study period. Following a one-week washout period, they will receive a single 75 mg dose of Rimegepant orally disintegrating tablet (RIPEVA), manufactured by Dr. Abidi Pharmaceutical Company (Test product), during the second study period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The concentration of the drug in blood. Timepoint: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h after drug. Method of measurement: Liquid Chromatography with Mass-Mass Detector.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded. This is done after completing the device analysis of the samples and through the WinNonLine software developed by Phoenix Company.</sec_outcome>
      <sec_outcome>Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.</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>Abidi Pharmaceutical Company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-09-21</approval_date>
        <contact_name>Tabriz University of Medical Sciences ethics committe</contact_name>
        <contact_address>Vice-Chancellery for Research and Technology, 3rd Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street, 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>
