<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/NCT01677247</url>
  </required_header>
  <id_info>
    <org_study_id>BE-Glimepiride</org_study_id>
    <nct_id>NCT01677247</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of 4 mg Glimepiride Tablet</brief_title>
  <official_title>Bioequivalence Study of Two Formulations of Glimepiride Tablet in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dexa Medica Group</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dexa Medica Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a randomized, single blind, two-period, two sequence cross-over study under fasting&#xD;
      condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test&#xD;
      and reference formulations).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participating subjects were required to have an overnight fast; and in the next morning&#xD;
      they were given orally either one tablet of 4 mg glimepiride as the test drug (produced by PT&#xD;
      Dexa Medica) or one tablet of 4 mg glimepiride (Amaryl®, Sanofi Aventis) as the reference&#xD;
      drug with 200 mL water.&#xD;
&#xD;
      Blood samples were drawn immediately before taking the drug (control), and at 0.5, 1, 1.5, 2,&#xD;
      2.5, 3, 3.5, 4.5, 6, 9, 12, 18 and 24 hours after drug administration. Immediately after drug&#xD;
      administration, subjects were administered 100 ml of 10% glucose at approximately 0.5, 1.5,&#xD;
      2, 2.5, 3.5, and 4.5 hours. In addition, 20% glucose solution was given to any subject who&#xD;
      exhibited symptoms of hypoglycaemia. One week after the first drug administration (wash-out&#xD;
      period), the procedure was repeated using the alternate drug.&#xD;
&#xD;
      The plasma concentrations of glimepiride were determined by high performance liquid&#xD;
      chromatography with ultraviolet detection (HPLC-UV). The pharmacokinetic parameters assessed&#xD;
      are AUCt, AUCinf, Cmax, tmax, and t1/2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">March 2011</completion_date>
  <primary_completion_date type="Actual">March 2011</primary_completion_date>
  <phase>N/A</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bioavailability</measure>
    <time_frame>24 hours</time_frame>
    <description>Relative bioavailability (primarily measured by AUC and Cmax) between two glimepiride 4 mg tablet formulations (test and reference formulations) under fasting condition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bioavailability</measure>
    <time_frame>24 hours</time_frame>
    <description>Relative bioavailability (secondarily measured by tmax and t1/2) between two formulations of glimepiride 4 mg tablets (the Test and Reference formulations)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>1 months</time_frame>
    <description>The presence of adverse events will be observed, reported and sufficiently handled during subjects' participation in the study (1 month).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Glimepiride BE Study in Healthy Volunteers Under Fasting Condition</condition>
  <arm_group>
    <arm_group_label>Group I (Test)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test : glimepiride 4 mg tablet of PT Dexa Medica</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (Reference)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reference : glimepiride (Amaryl) 4 mg tablet of PT Sanofi-Aventis, Indonesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica</intervention_name>
    <description>In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.</description>
    <arm_group_label>Group I (Test)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis</intervention_name>
    <description>In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.</description>
    <arm_group_label>Group II (Reference)</arm_group_label>
    <other_name>Amaryl®, manufactured by PT Sanofi Aventis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects with absence of significant disease or clinically significant&#xD;
             abnormal laboratory values on laboratory evaluation, medical history or physical&#xD;
             examination during screening&#xD;
&#xD;
          2. Age of 18 - 55 years&#xD;
&#xD;
          3. Preferably non-smokers or moderate smokers (less than 10 cigarettes per day)&#xD;
&#xD;
          4. Able to participate, communicate well with the investigators and willing to provide&#xD;
             written informed consent to participate in the study&#xD;
&#xD;
          5. BMI 18 - 25 kg/m2&#xD;
&#xD;
          6. Vital signs (after 10 minutes rest) must be within the following ranges:&#xD;
&#xD;
               -  SBP 100 - 120 mmHg&#xD;
&#xD;
               -  DBP 60 - 80 mmHg&#xD;
&#xD;
               -  Pulse rate 60 - 90 bpm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Personal/family history of allergy or hypersensitivity or contraindication to&#xD;
             glimepiride or allied drugs&#xD;
&#xD;
          2. Pregnant or lactating women&#xD;
&#xD;
          3. Any major illnesses in the past 90 days or clinically significant ongoing chronic&#xD;
             medical illness&#xD;
&#xD;
          4. Presence of any clinically significant abnormal values during screening&#xD;
&#xD;
          5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV&#xD;
&#xD;
          6. Clinically significant haematology abnormalities&#xD;
&#xD;
          7. Clinically significant electrocardiogram (ECG) abnormalities&#xD;
&#xD;
          8. Any surgical or medical condition (present or history) which might significantly alter&#xD;
             the absorption, distribution, metabolism or excretion of the study drug&#xD;
&#xD;
          9. Past history of anaphylaxis or angioedema&#xD;
&#xD;
         10. History of drug or alcohol abuse within 12 months prior to screening&#xD;
&#xD;
         11. Participation in any clinical trial within the past 90 days&#xD;
&#xD;
         12. History of any bleeding or coagulative disorders&#xD;
&#xD;
         13. History of difficulty with donating blood or difficulty in accessibility of veins in&#xD;
             left or right arm&#xD;
&#xD;
         14. A donation or loss of 500 mL (or more) of blood within 3 months before this study's&#xD;
             first dosing day&#xD;
&#xD;
         15. Intake of any prescription, non-prescription drug, food supplements or herbal&#xD;
             medicines within 14 days of this study's first dosing day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danang A. Yunaidi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PT Equilab International</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PT Equilab International</name>
      <address>
        <city>Jakarta</city>
        <zip>12430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <reference>
    <citation>Salem II, Idrees J, Al Tamimi JI. Determination of glimepiride in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Jan 5;799(1):103-9. doi: 10.1016/j.jchromb.2003.10.024.</citation>
    <PMID>14659441</PMID>
  </reference>
  <reference>
    <citation>Jovanovic D, Stojsic D, Zlatkovic M, Jovic-Stosic J, Jovanovic M. Bioequivalence assessment of the two brands of glimepiride tablets. Vojnosanit Pregl. 2006 Dec;63(12):1015-20. doi: 10.2298/vsp0612015j.</citation>
    <PMID>17252706</PMID>
  </reference>
  <reference>
    <citation>Malerczyk V, Badian M, Korn A, Lehr KH, Waldhausl W. Dose linearity assessment of glimepiride (Amaryl) tablets in healthy volunteers. Drug Metabol Drug Interact. 1994;11(4):341-57. doi: 10.1515/dmdi.1994.11.4.341.</citation>
    <PMID>12369757</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>August 30, 2012</last_update_submitted>
  <last_update_submitted_qc>August 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sulphonylurea</keyword>
  <keyword>anti-hyperglycaemic</keyword>
  <keyword>bioavailability</keyword>
  <keyword>bioequivalence</keyword>
  <keyword>glimepiride</keyword>
  <keyword>pharmacokinetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glimepiride</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/NCT01677247
org study id: BE-Glimepiride
nct id: NCT01677247
lead sponsor: 
has dmc: No
This was a randomized, single blind, two-period, two sequence cross-over study under fasting
      condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test
      and reference formulations).
The participating subjects were required to have an overnight fast; and in the next morning
      they were given orally either one tablet of 4 mg glimepiride as the test drug (produced by PT
      Dexa Medica) or one tablet of 4 mg glimepiride (Amaryl®, Sanofi Aventis) as the reference
      drug with 200 mL water.

      Blood samples were drawn immediately before taking the drug (control), and at 0.5, 1, 1.5, 2,
      2.5, 3, 3.5, 4.5, 6, 9, 12, 18 and 24 hours after drug administration. Immediately after drug
      administration, subjects were administered 100 ml of 10% glucose at approximately 0.5, 1.5,
      2, 2.5, 3.5, and 4.5 hours. In addition, 20% glucose solution was given to any subject who
      exhibited symptoms of hypoglycaemia. One week after the first drug administration (wash-out
      period), the procedure was repeated using the alternate drug.

      The plasma concentrations of glimepiride were determined by high performance liquid
      chromatography with ultraviolet detection (HPLC-UV). The pharmacokinetic parameters assessed
      are AUCt, AUCinf, Cmax, tmax, and t1/2.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Bioavailability
time frame: 24 hours
description: Relative bioavailability (primarily measured by AUC and Cmax) between two glimepiride 4 mg tablet formulations (test and reference formulations) under fasting condition.
measure: Bioavailability
time frame: 24 hours
description: Relative bioavailability (secondarily measured by tmax and t1/2) between two formulations of glimepiride 4 mg tablets (the Test and Reference formulations)
measure: Adverse events
time frame: 1 months
description: The presence of adverse events will be observed, reported and sufficiently handled during subjects' participation in the study (1 month).
arm group label: Group I (Test)
arm group type: Experimental
description: Test : glimepiride 4 mg tablet of PT Dexa Medica
arm group label: Group II (Reference)
arm group type: Active Comparator
description: Reference : glimepiride (Amaryl) 4 mg tablet of PT Sanofi-Aventis, Indonesia
intervention type: Drug
intervention name: Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica
description: In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.
arm group label: Group I (Test)
intervention type: Drug
intervention name: Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis
description: In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.
arm group label: Group II (Reference)
other name: Amaryl®, manufactured by PT Sanofi Aventis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Danang A. Yunaidi, MD
role: Principal Investigator
affiliation: PT Equilab International
facility: 
country: Indonesia
citation: Salem II, Idrees J, Al Tamimi JI. Determination of glimepiride in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Jan 5;799(1):103-9. doi: 10.1016/j.jchromb.2003.10.024.
PMID: 14659441
citation: Jovanovic D, Stojsic D, Zlatkovic M, Jovic-Stosic J, Jovanovic M. Bioequivalence assessment of the two brands of glimepiride tablets. Vojnosanit Pregl. 2006 Dec;63(12):1015-20. doi: 10.2298/vsp0612015j.
PMID: 17252706
citation: Malerczyk V, Badian M, Korn A, Lehr KH, Waldhausl W. Dose linearity assessment of glimepiride (Amaryl) tablets in healthy volunteers. Drug Metabol Drug Interact. 1994;11(4):341-57. doi: 10.1515/dmdi.1994.11.4.341.
PMID: 12369757
responsible party type: Sponsor
mesh term: Glimepiride