<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/NCT01674504</url>
  </required_header>
  <id_info>
    <org_study_id>741/09</org_study_id>
    <nct_id>NCT01674504</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg 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 chewable tablets 4mg and 5mg of&#xD;
      Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (containing&#xD;
      Montelukast sodium) chewable tablets 4mg and 5 mg of Merck Sharp &amp; Dohme Ltd., USA in&#xD;
      healthy, adult, human subjects under fasting conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">January 2010</completion_date>
  <primary_completion_date type="Actual">January 2010</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>Blood samples were withdrawn at predose (0.00) and 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Montelukast sodium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Montelukast sodium chewable tablets 4mg and 5mg of Dr. Reddy's Laboratories Limited</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SINGTJLAIR ®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SINGTJLAIR ® (containing Montelukast sodium)chewable tablets 5mg of Merck Sharp &amp; Dohme Ltd., USA</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Montelukast sodium chewable tablets 4 mg and 5 mg</intervention_name>
    <description>Montelukast sodium chewable tablets 4mg and 5mg</description>
    <arm_group_label>Montelukast sodium</arm_group_label>
    <arm_group_label>SINGTJLAIR ®</arm_group_label>
    <other_name>SINGTJLAIR ®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects were selected based on the following inclusion criteria:&#xD;
&#xD;
          -  Provide written informed consent.&#xD;
&#xD;
          -  Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive)&#xD;
             weighing at least 50 kg.&#xD;
&#xD;
          -  Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight&#xD;
             in Kg/height in m2.&#xD;
&#xD;
          -  Must be of normal health as determined by medical history, physical examination and&#xD;
             laboratory investigation performed within 28 days prior to the commencement of the&#xD;
             study. (Laboratory values must be within normal limits or considered by the physician&#xD;
             I investigator to be of no clinical significance).&#xD;
&#xD;
          -  Female Subjects&#xD;
&#xD;
          -  Of child bearing potential practicing an acceptable method of birth control for the&#xD;
             duration of the study as judged by the investigator(s), such as condoms, foams,&#xD;
             jellies, diaphragm, intrauterine device (IUD), or abstinence.&#xD;
&#xD;
          -  Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy&#xD;
             has been performed on the subject)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        The subjects were excluded based on the following criteria during screening and during the&#xD;
        study:&#xD;
&#xD;
          -  Incapable of understanding the informed consent.&#xD;
&#xD;
          -  Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.&#xD;
&#xD;
          -  Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.&#xD;
&#xD;
          -  Oral temperature is below 95.0°F or above 98.6°F.&#xD;
&#xD;
          -  Pulse rate below 50/min or above 100/min.&#xD;
&#xD;
          -  History of hypersensitivity or idiosyncratic reaction to investigational drug product&#xD;
             or any other related drugs.&#xD;
&#xD;
          -  Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal&#xD;
             function.&#xD;
&#xD;
          -  Consumption of grapefruit for the past ten days prior to the check-in, in each period.&#xD;
&#xD;
          -  Regular smoker who has a habit of smoking more than nine cigarettes per day and has&#xD;
             difficulty in abstaining from smoking during sample collection period.&#xD;
&#xD;
          -  Habit of alcoholism and difficulty in abstaining from alcohol during the sample&#xD;
             collection period.&#xD;
&#xD;
          -  Difficulty in abstaining from xanthene containing food or beverages (like tea, coffee,&#xD;
             chocolates and cola drinks) during the sample collection period.&#xD;
&#xD;
          -  Intake of over the counter (OTC) or prescribed medications and enzyme modifying&#xD;
             medication or systemic medication for the last 30 days before dosing.&#xD;
&#xD;
          -  Clinically significant abnormalities and / or with significant diseases.&#xD;
&#xD;
          -  Prevalence of oral candidiasis, aphthous ulcer or other oral lesions.&#xD;
&#xD;
          -  Difficulty in swallowing tablets/capsules.&#xD;
&#xD;
          -  Confirmed positive in alcohol screening.&#xD;
&#xD;
          -  Confirmed positive in selected drug of abuse.&#xD;
&#xD;
          -  Participated in any other clinical investigation using experimental drug/donated blood&#xD;
             in past 90 days before the date of start of study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dwarakanath A, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bioserve Clinical Research Private Limited,</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bioserve Clinical Research Private Limited</name>
      <address>
        <city>Balanagar</city>
        <state>Hyderabad</state>
        <zip>500 037</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 24, 2012</last_update_submitted>
  <last_update_submitted_qc>August 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 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/NCT01674504
org study id: 741/09
nct id: NCT01674504
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 chewable tablets 4mg and 5mg of
      Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (containing
      Montelukast sodium) chewable tablets 4mg and 5 mg 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: Blood samples were withdrawn at predose (0.00) and 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose.
arm group label: Montelukast sodium
arm group type: Experimental
description: Montelukast sodium chewable tablets 4mg and 5mg of Dr. Reddy's Laboratories Limited
arm group label: SINGTJLAIR ®
arm group type: Active Comparator
description: SINGTJLAIR ® (containing Montelukast sodium)chewable tablets 5mg of Merck Sharp & Dohme Ltd., USA
intervention type: Drug
intervention name: Montelukast sodium chewable tablets 4 mg and 5 mg
description: Montelukast sodium chewable tablets 4mg and 5mg
arm group label: Montelukast sodium
arm group label: SINGTJLAIR ®
other name: SINGTJLAIR ®
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dwarakanath A, Dr.
role: Principal Investigator
affiliation: Bioserve Clinical Research Private Limited,
facility: 
country: India
responsible party type: Sponsor
mesh term: Montelukast