<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/NCT01694797</url>
  </required_header>
  <id_info>
    <org_study_id>642/09</org_study_id>
    <nct_id>NCT01694797</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting Condition</brief_title>
  <official_title>An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metoprolol Succinate Extended-Release Tablets 50 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of TOPROL-XL® (Containing Metoprolol Succinate) Extended-Release Tablets 50 mg of AstraZeneca LP Wilmington, DE 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol&#xD;
      Succinate Extended-Release Tablets 50 mg under fasting conditions&#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 Metoprolol Succinate Extended-Release tablets 50 mg&#xD;
      of Dr. Reddy's Laboratories Limited,under fasting conditions&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">January 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 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Metoprolol Succinate ER Tablets, 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Metoprolol Succinate ER Tablets, 50 mg of Dr.Reddy's Laboratories Ltd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TOPROL-XL ER Tablets 50 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TOPROL-XL ER Tablets 50 mg of AstraZeneca</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metoprolol Succinate</intervention_name>
    <arm_group_label>Metoprolol Succinate ER Tablets, 50 mg</arm_group_label>
    <arm_group_label>TOPROL-XL ER Tablets 50 mg</arm_group_label>
    <other_name>TOPROL-XL®</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 between 18 and 45 years of age(both inclusive)&#xD;
             weighing at least 50 kg.&#xD;
&#xD;
          -  Having a body mass index between 18.5 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&#xD;
             physician/investigator to be of no clinical significance).&#xD;
&#xD;
          -  Female Subjects of child bearing potential practicing an acceptable method of birth&#xD;
             control for the duration of the study as judged by the investigator (s),such as&#xD;
             condoms, foams, 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;
          -  Habit of tobacco chewing.&#xD;
&#xD;
          -  Habit of alcoholism and difficulty in abstaining from alcohol during the sample&#xD;
             collection 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;
          -  Difficulty in abstaining from xanthine 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 lor with significant diseases.&#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;
&#xD;
          -  Confirmed positive in urine pregnancy test.&#xD;
&#xD;
          -  Female detected to be pregnant, breast feeding or who is likely to become pregnant&#xD;
             during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Dr. P. Vijaya Lakshmi, Clinical Investigator</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>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>500 037</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2010</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>September 27, 2012</last_update_submitted>
  <last_update_submitted_qc>September 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metoprolol</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/NCT01694797
org study id: 642/09
nct id: NCT01694797
lead sponsor: 
has dmc: Yes
The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol
      Succinate Extended-Release Tablets 50 mg under fasting conditions
An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose,
      crossover, oral bioequivalence study of Metoprolol Succinate Extended-Release tablets 50 mg
      of Dr. Reddy's Laboratories Limited,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 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose.
arm group label: Metoprolol Succinate ER Tablets, 50 mg
arm group type: Experimental
description: Metoprolol Succinate ER Tablets, 50 mg of Dr.Reddy's Laboratories Ltd
arm group label: TOPROL-XL ER Tablets 50 mg
arm group type: Active Comparator
description: TOPROL-XL ER Tablets 50 mg of AstraZeneca
intervention type: Drug
intervention name: Metoprolol Succinate
arm group label: Metoprolol Succinate ER Tablets, 50 mg
arm group label: TOPROL-XL ER Tablets 50 mg
other name: TOPROL-XL®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. P. Vijaya Lakshmi, Clinical Investigator
role: Principal Investigator
affiliation: Bioserve Clinical Research Private Limited
facility: 
country: India
responsible party type: Sponsor
mesh term: Metoprolol