<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/NCT01691456</url>
  </required_header>
  <id_info>
    <org_study_id>539-10</org_study_id>
    <nct_id>NCT01691456</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fasting 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 Fasting 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 fasting&#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, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 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">45</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>
  <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/NCT01691456
org study id: 539-10
nct id: NCT01691456
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 fasting
      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, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 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: Montelukast