<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/NCT01735383</url>
  </required_header>
  <id_info>
    <org_study_id>Ipca/VIN-11/412</org_study_id>
    <nct_id>NCT01735383</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fed Condition</brief_title>
  <official_title>An Open Label, Balanced, Randomized, Single-dose, Two-treatment, Two-sequence, Two-period, Crossover, Oral Bioequivalence Study of Etodolac Tablets USP 500mg of Ipca Laboratories Limited, India and Etodolac Tablets USP 500mg of Taro Pharmaceutical Industries Ltd., USA in Healthy, Adult, Human Subjects Under Fed Condition.</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 open Label, balanced, randomized, single dose, two-treatment, two-sequence,&#xD;
      two-period, crossover pivotal study. The purpose of this study is to assess the&#xD;
      bioequivalence between Test Product and the corresponding Reference Product under fed&#xD;
      condition in healthy, adult human subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective of this pivotal study was to assess the bioequivalence between Test Product:&#xD;
      Etodolac Tablets USP 500 mg of Ipca Laboratories Limited, India and the corresponding&#xD;
      Reference Product: Etodolac Tablets USP 500mg of Taro Pharmaceutical Industries Ltd., USA,&#xD;
      under fed condition in healthy, adult, human subjects in a randomized crossover study.&#xD;
&#xD;
      The study was conducted with 36 healthy adult subjects. In each study period, a single 500 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 7&#xD;
      days between administrations of study drug in each study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 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>Cmax</measure>
    <time_frame>2 months</time_frame>
    <description>Sampling Hours: Pre-dose and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>2 months</time_frame>
    <description>Sampling Hours: Pre-dose and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post dose.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Fed</condition>
  <arm_group>
    <arm_group_label>Etodolac Tablets USP 500mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Etodolac Tablets USP 500 mg of Ipca Laboratories Limited, India</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Etodolac Tablets USP 500 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Etodolac Tablets USP 500 mg of Taro Pharmaceutical Industries Ltd., USA</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etodolac Tablets USP 500mg</intervention_name>
    <description>500 mg tablet once a day</description>
    <arm_group_label>Etodolac Tablets USP 500mg</arm_group_label>
    <other_name>Test Product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etodolac Tablets USP 500 mg</intervention_name>
    <description>500 mg tablet once a day</description>
    <arm_group_label>Etodolac Tablets USP 500 mg</arm_group_label>
    <other_name>Reference Product</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male and non-pregnant female subjects within the age range of 18 to 45 years&#xD;
             (both inclusive), at the time of dosing.&#xD;
&#xD;
          2. Subjects' weight within normal range according to normal values for Body Mass Index&#xD;
             (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.&#xD;
&#xD;
          3. Subjects with normal health as determined by personal medical and medication history,&#xD;
             clinical examination and laboratory examinations within the clinically acceptable&#xD;
             reference range.&#xD;
&#xD;
          4. Subjects having normal 12-lead electrocardiogram (ECG).&#xD;
&#xD;
          5. Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken within 6 months&#xD;
             prior to the dosing of Period 01.&#xD;
&#xD;
          6. Subjects having negative urine screen for drugs of abuse (including amphetamines,&#xD;
             barbiturates, benzodiazepines, marijuana, cocaine, and morphine).&#xD;
&#xD;
          7. Subjects having negative alcohol breath test.&#xD;
&#xD;
          8. Subjects willing to adhere to protocol requirements and to provide written informed&#xD;
             consent.&#xD;
&#xD;
          9. Subjects having negative Beta-hCG Pregnancy test (only for female subjects).&#xD;
&#xD;
         10. For Female Subjects:&#xD;
&#xD;
               -  Female 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, or&#xD;
&#xD;
               -  Postmenopausal for at least 1 years, or if less than 1 years, then following&#xD;
                  acceptable contraceptive measures as mentioned above&#xD;
&#xD;
               -  Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or&#xD;
                  hysterectomy has been performed on the subject).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to Etodolac or related class of drugs.&#xD;
&#xD;
          2. History or presence of significant cardiovascular, pulmonary, hepatic, renal,&#xD;
             gastrointestinal, endocrine, immunological, dermatological, neurological or&#xD;
             psychiatric disease or disorder.&#xD;
&#xD;
          3. History or presence of significant alcoholism or drug abuse.&#xD;
&#xD;
          4. History or presence of significant smoking (more than 10 cigarettes or beedi's/day).&#xD;
&#xD;
          5. History or presence of significant asthma, urticaria or other allergic reactions.&#xD;
&#xD;
          6. History or presence of significant gastric and/or duodenal ulceration.&#xD;
&#xD;
          7. History or presence of significant thyroid disease, adrenal dysfunction, organic&#xD;
             intracranial lesion such as pituitary tumour.&#xD;
&#xD;
          8. History or presence of cancer.&#xD;
&#xD;
          9. Difficulty with donating blood.&#xD;
&#xD;
         10. Difficulty in swallowing solids like tablets or capsules.&#xD;
&#xD;
         11. Use of any prescribed medication or OTC medical products during last two weeks prior&#xD;
             to dosing in period 01.&#xD;
&#xD;
         12. Major illness during 3 months before screening.&#xD;
&#xD;
         13. Participation in a drug research study within past 3 months.&#xD;
&#xD;
         14. Donation of blood in the past 3 months before screening.&#xD;
&#xD;
         15. Consumption of grapefruit juice, xanthine-containing products, tobacco containing&#xD;
             products or alcohol within 48 hours prior to dosing.&#xD;
&#xD;
         16. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.&#xD;
&#xD;
         17. History or presence of significant easy bruising or bleeding.&#xD;
&#xD;
         18. History or presence of significant recent trauma.&#xD;
&#xD;
         19. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks&#xD;
             preceding the study.&#xD;
&#xD;
         20. Female subjects who are currently on breast feeding.&#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. Hardik Dave, M.B.B.S.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Veeda Clinical Research Pvt. Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Veeda Clinical Research Pvt. Ltd.</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 30, 2012</last_update_submitted>
  <last_update_submitted_qc>November 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 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>Etodolac</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/NCT01735383
org study id: Ipca/VIN-11/412
nct id: NCT01735383
lead sponsor: 
has dmc: Yes
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,
      two-period, 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 healthy, adult human subjects.
Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Etodolac Tablets USP 500 mg of Ipca Laboratories Limited, India and the corresponding
      Reference Product: Etodolac Tablets USP 500mg of Taro Pharmaceutical Industries Ltd., USA,
      under fed condition in healthy, adult, human subjects in a randomized crossover study.

      The study was conducted with 36 healthy adult subjects. In each study period, a single 500 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 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: Cmax
time frame: 2 months
description: Sampling Hours: Pre-dose and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post dose.
measure: AUC
time frame: 2 months
description: Sampling Hours: Pre-dose and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post dose.
arm group label: Etodolac Tablets USP 500mg
arm group type: Experimental
description: Etodolac Tablets USP 500 mg of Ipca Laboratories Limited, India
arm group label: Etodolac Tablets USP 500 mg
arm group type: Active Comparator
description: Etodolac Tablets USP 500 mg of Taro Pharmaceutical Industries Ltd., USA
intervention type: Drug
intervention name: Etodolac Tablets USP 500mg
description: 500 mg tablet once a day
arm group label: Etodolac Tablets USP 500mg
other name: Test Product
intervention type: Drug
intervention name: Etodolac Tablets USP 500 mg
description: 500 mg tablet once a day
arm group label: Etodolac Tablets USP 500 mg
other name: Reference Product
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Hardik Dave, M.B.B.S.
role: Principal Investigator
affiliation: Veeda Clinical Research Pvt. Ltd.
facility: 
country: India
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Etodolac