<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/NCT01722110</url>
  </required_header>
  <id_info>
    <org_study_id>Ipca/ARL-10/436</org_study_id>
    <nct_id>NCT01722110</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg Under Fed Condition</brief_title>
  <official_title>A Randomized, Balanced, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg of Ipca Laboratories Ltd., With Indomethacin Extended-Release Capsules USP 75 mg of Epic Pharma, USA, in Normal, Healthy, Adult, Male and Female Human Subjects Under Fed Conditions.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IPCA Laboratories Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IPCA Laboratories Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single&#xD;
      dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence&#xD;
      between Test Product and the corresponding Reference Product under fed condition in normal,&#xD;
      healthy, adult, male and female human subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective of this pivotal study was to assess the bioequivalence between Test Product:&#xD;
      Indomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India and the&#xD;
      corresponding Reference Product: Indomethacin Extended-Release Capsules USP 75 mg of Epic&#xD;
      Pharma, USA, under fed condition in normal, healthy, adult, male and female human subjects in&#xD;
      a randomized crossover study.&#xD;
&#xD;
      The study was conducted with 32 healthy adult subjects. In each study period, a single 75 mg&#xD;
      dose of either test or reference was administered to the subjects as per the randomization&#xD;
      schedule in each study period with about 240 mL of water at ambient temperature in sitting&#xD;
      position.&#xD;
&#xD;
      The duration of the clinical phase was approximately 10 days including washout period of at&#xD;
      least 7 days between administrations of study drug in each study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Bioequivalence is based on Cmax and AUC parameters.</measure>
    <time_frame>2 months</time_frame>
    <description>Sampling Hours: Pre-dose and at 0.50, 1.00, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hrs post dose.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Fed</condition>
  <arm_group>
    <arm_group_label>Indomethacin Extended-Release Capsules USP 75 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Indomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indomethacin Extended Release Capsules USP 75 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Indomethacin Extended Release Capsules USP 75 mg of Epic Pharma, USA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indomethacin Extended-Release Capsules USP 75 mg</intervention_name>
    <description>75 mg tablet once a day</description>
    <arm_group_label>Indomethacin Extended-Release Capsules USP 75 mg</arm_group_label>
    <other_name>Test Product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indomethacin Extended Release Capsules USP 75 mg</intervention_name>
    <description>75 mg tablet once a day</description>
    <arm_group_label>Indomethacin Extended Release Capsules USP 75 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and non pregnant female human subjects, age in the range of 18 - 45 years.&#xD;
&#xD;
          2. Body weight within ± 15% of ideal weight as related to height and body frame according&#xD;
             to Life Insurance Corporation (LIC) Chart.&#xD;
&#xD;
          3. Subjects with normal findings as determined by baseline history, physical examination&#xD;
             and vital sign examination (blood pressure, pulse rate, respiration rate and axillary&#xD;
             temperature).&#xD;
&#xD;
          4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry,&#xD;
             urinalysis and 12 lead ECG.&#xD;
&#xD;
          5. Subject's willing to give written informed consent.&#xD;
&#xD;
          6. Willingness to follow the protocol requirements especially abstaining from xanthine&#xD;
             containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit&#xD;
             juice, any alcoholic products, the use of cigarettes and tobacco products for 48 hours&#xD;
             prior to dosing until after the last blood sample collection in each study period and&#xD;
             adherence to food, fluid and posture restrictions.&#xD;
&#xD;
          7. No history of significant alcoholism.&#xD;
&#xD;
          8. No history of drug abuse (benzodiazepines and barbiturates) for the last one month and&#xD;
             other illegal drugs for the last 6 months.&#xD;
&#xD;
          9. Non-smokers were included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known history of hypersensitivity to Indomethacin or related drugs.&#xD;
&#xD;
          2. Requiring medication for any ailment having enzyme-modifying activity in the previous&#xD;
             28 days, prior to dosing day.&#xD;
&#xD;
          3. Subjects who have taken prescription medications or over-the-counter products&#xD;
             (including vitamins and minerals) within 14 days prior to administration of&#xD;
             Investigational Product.&#xD;
&#xD;
          4. Any medical or surgical conditions, which might significantly interfere with the&#xD;
             functioning of gastrointestinal tract, blood-forming organs etc.&#xD;
&#xD;
          5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological,&#xD;
             metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric&#xD;
             diseases.&#xD;
&#xD;
          6. Participation in a clinical drug study or bioequivalence study 90 days prior to&#xD;
             present study.&#xD;
&#xD;
          7. History of malignancy or other serious diseases.&#xD;
&#xD;
          8. Blood donation 90 days prior to the commencement of the study.&#xD;
&#xD;
          9. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.&#xD;
&#xD;
         10. Found positive in breath alcohol test.&#xD;
&#xD;
         11. Found positive in urine test for drug abuse.&#xD;
&#xD;
         12. History of problem in swallowing.&#xD;
&#xD;
         13. Any contraindication to blood sampling.&#xD;
&#xD;
         14. Found positive serum Beta- hCG (Human Chorionic Gonadotropin) test.&#xD;
&#xD;
         15. Lactating women (currently breast feeding).&#xD;
&#xD;
         16. Female subjects not confirming to using birth control measures, from the date of&#xD;
             screening until the completion of the study. Abstinence, barrier methods (condom,&#xD;
             diaphragm, etc.) were acceptable. Use of hormonal contraceptives either oral or&#xD;
             implants.&#xD;
&#xD;
         17. Female subjects whose menstruation cycle coincided with the study periods.&#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. Suhas Khandave, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Accutest Research Lab (I) Pvt. Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Accutest Research Lab (I) Pvt. Ltd.</name>
      <address>
        <city>Navi-Mumbai</city>
        <state>Maharashtra</state>
        <zip>400 709</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>November 2, 2012</last_update_submitted>
  <last_update_submitted_qc>November 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Indomethacin</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/NCT01722110
org study id: Ipca/ARL-10/436
nct id: NCT01722110
lead sponsor: 
has dmc: Yes
This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single
      dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fed condition in normal,
      healthy, adult, male and female human subjects.
Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Indomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India and the
      corresponding Reference Product: Indomethacin Extended-Release Capsules USP 75 mg of Epic
      Pharma, USA, under fed condition in normal, healthy, adult, male and female human subjects in
      a randomized crossover study.

      The study was conducted with 32 healthy adult subjects. In each study period, a single 75 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 10 days including washout period of at
      least 7 days between administrations of study drug in each study period.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bioequivalence is based on Cmax and AUC parameters.
time frame: 2 months
description: Sampling Hours: Pre-dose and at 0.50, 1.00, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hrs post dose.
arm group label: Indomethacin Extended-Release Capsules USP 75 mg
arm group type: Experimental
description: Indomethacin Extended-Release Capsules USP 75 mg of Ipca Laboratories Limited, India
arm group label: Indomethacin Extended Release Capsules USP 75 mg
arm group type: Active Comparator
description: Indomethacin Extended Release Capsules USP 75 mg of Epic Pharma, USA.
intervention type: Drug
intervention name: Indomethacin Extended-Release Capsules USP 75 mg
description: 75 mg tablet once a day
arm group label: Indomethacin Extended-Release Capsules USP 75 mg
other name: Test Product
intervention type: Drug
intervention name: Indomethacin Extended Release Capsules USP 75 mg
description: 75 mg tablet once a day
arm group label: Indomethacin Extended Release Capsules USP 75 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Suhas Khandave, M.D.
role: Principal Investigator
affiliation: Accutest Research Lab (I) Pvt. Ltd.
facility: 
country: India
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Indomethacin