<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01691469</url>
  </required_header>
  <id_info>
    <org_study_id>540-10</org_study_id>
    <nct_id>NCT01691469</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fed Condition</brief_title>
  <official_title>An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fed Conditions.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Reddy's Laboratories Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. Reddy's Laboratories Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single&#xD;
      dose, crossover, oral bioequivalence study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,&#xD;
      crossover, oral bioequivalence study of Montelukast Sodium Oral Granules 4mg of Dr. Reddy's&#xD;
      Laboratories Limited, India comparing with that of SINGULAIR® (Montelukast sodium) 4mg oral&#xD;
      granules of Merck Sharp &amp; Dohme Ltd., USA in healthy, adult, human subjects under fed&#xD;
      conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">February 2011</completion_date>
  <primary_completion_date type="Actual">January 2011</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under curve(AUC)</measure>
    <time_frame>Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 12.00, 16.00, 20.00 and 24.00 hours post dose.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Montelukast Sodium Oral Granules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SINGULAIR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>(Montelukast sodium) Oral Granules 4mg of Merck Sharp &amp; Dohme Ltd., USA</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Montelukast sodium</intervention_name>
    <description>Montelukast Sodium Oral Granules 4mg</description>
    <arm_group_label>Montelukast Sodium Oral Granules</arm_group_label>
    <arm_group_label>SINGULAIR</arm_group_label>
    <other_name>SINGULAIR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must fulfill the following criteria to be considered for inclusion into this&#xD;
        study.&#xD;
&#xD;
          -  Healthy subjects within the age range of 18 to 50 years.&#xD;
&#xD;
          -  A body mass index between 18.5 to 24.9 Kg/m2&#xD;
&#xD;
          -  Given written informed consent to participate in the study.&#xD;
&#xD;
          -  Absence of disease markers of HIV 1 &amp; 2, hepatitis B &amp; C virus and RPR.&#xD;
&#xD;
          -  Absence of significant disease or clinically significant abnormal laboratory values on&#xD;
             laboratory evaluation, medical history and physical examination during the screening.&#xD;
&#xD;
          -  A normal 12-lead ECG.&#xD;
&#xD;
          -  A normal chest X-ray (PA view).&#xD;
&#xD;
          -  Compliance with the requirement of the entire protocol.&#xD;
&#xD;
          -  No history or no evidence of hypersensitivity to Montelukast and to any component of&#xD;
             the formulation.&#xD;
&#xD;
          -  No history of gastrointestinal problems (ulcers).&#xD;
&#xD;
          -  No history of significant systemic diseases.&#xD;
&#xD;
          -  No history of psychiatric disorders.&#xD;
&#xD;
          -  No history of allergic rash.&#xD;
&#xD;
          -  No history of addiction to any recreational drug or drug dependence.&#xD;
&#xD;
          -  No donation of blood (one unit or 350 mL) within 90 days prior to study check in.&#xD;
&#xD;
          -  No Participation in any clinical study within the past 90 days.&#xD;
&#xD;
          -  No receipt of any prescription drugs or over-the-counter drugs (e.g.: Cold&#xD;
             preparations, and antacid preparations vitamins and natural products used for&#xD;
             therapeutic benefits), within two weeks prior to study check-in.&#xD;
&#xD;
          -  No history of dehydration from dialThea, vomiting or any other reason within a period&#xD;
             of24.0 hours prior to study check-in.&#xD;
&#xD;
          -  No family history of neurological disorders. Not consumed alcohol and xanthine&#xD;
             containing food and beverages (chocolates, tea, coffee or cola drink:s), cigarettes&#xD;
             and tobacco products, for at least 48.0 hours prior to study check-in.&#xD;
&#xD;
          -  Negative results for drugs of abuse (Benzodiazepines, Cocaines, Opioids, Amphetamines,&#xD;
             Ca1U1abinoids and Barbiturates) in urine during the day of study check-in.&#xD;
&#xD;
          -  Not consumed grapefruit (mosumbi/sweet lime) juice within the 48.0 hours prior to&#xD;
             study check-in.&#xD;
&#xD;
          -  Negative alcohol breath analysis during the study check-in.&#xD;
&#xD;
          -  Female volunteers demonstrating a negative pregnancy test.&#xD;
&#xD;
          -  If study volunteer is a female volunteer and is of child bearing potential practicing&#xD;
             an acceptable method of birth control for the duration of the study as judged by the&#xD;
             investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device&#xD;
             (IUD), or abstinence.&#xD;
&#xD;
        or is postmenopausal for at least 1 year. or is surgically . sterile (bilateral tubal&#xD;
        ligation, bilateral oophorectomy or hysterectomy has been performed on the study&#xD;
        volunteer).&#xD;
&#xD;
        Exclusion Criteria The subjects were excluded based on the following criteria.&#xD;
&#xD;
          -  History of seizures.&#xD;
&#xD;
          -  Received pharmacological agents known to significantly induce or inhibit drug&#xD;
             metabolizing enzymes within 14 days of the start of the study.&#xD;
&#xD;
          -  History of alcohol consumption for more than two units/day (1 unit = 30 mL of&#xD;
             spirit/or 1 pint of beer), or having consumed alcohol within 48 hours prior to&#xD;
             check-in.&#xD;
&#xD;
          -  High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9&#xD;
             cigarettes/beedies/cigars per day) consumption.&#xD;
&#xD;
          -  History of difficulty with donating blood or difficulty in accessibility of veins.&#xD;
&#xD;
          -  An unusual or abnormal diet, for whatever reason e.g. because of fasting due to&#xD;
             religious reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>A. Jayachandra Reddy, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Axis Clinicals Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AXIS Clinicals Limited,</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500 049</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>September 20, 2012</last_update_submitted>
  <last_update_submitted_qc>September 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bioequivalence</keyword>
  <keyword>Montelukast Sodium</keyword>
  <keyword>crossover</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Montelukast</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01691469
org study id: 540-10
nct id: NCT01691469
lead sponsor: 
has dmc: No
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover, oral bioequivalence study.
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of Montelukast Sodium Oral Granules 4mg of Dr. Reddy's
      Laboratories Limited, India comparing with that of SINGULAIR® (Montelukast sodium) 4mg oral
      granules of Merck Sharp & Dohme Ltd., USA in healthy, adult, human subjects under fed
      conditions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under curve(AUC)
time frame: Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 12.00, 16.00, 20.00 and 24.00 hours post dose.
arm group label: Montelukast Sodium Oral Granules
arm group type: Experimental
description: Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited
arm group label: SINGULAIR
arm group type: Active Comparator
description: (Montelukast sodium) Oral Granules 4mg of Merck Sharp & Dohme Ltd., USA
intervention type: Drug
intervention name: Montelukast sodium
description: Montelukast Sodium Oral Granules 4mg
arm group label: Montelukast Sodium Oral Granules
arm group label: SINGULAIR
other name: SINGULAIR
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: A. Jayachandra Reddy, Dr.
role: Principal Investigator
affiliation: Axis Clinicals Limited
facility: 
country: India
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Montelukast