<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/NCT01735344</url>
  </required_header>
  <id_info>
    <org_study_id>Ipca/ARL-10/385</org_study_id>
    <nct_id>NCT01735344</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Lisinopril Tablets 40 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 Lisinopril Tablets 40 mg With Zestril® (Lisinopril) 40 mg Tablets 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;
      Lisinopril Tablets 40 mg of Ipca Laboratories Limited, India and the corresponding Reference&#xD;
      Product: Zestril® (Lisinopril) 40 mg Tablets of AstraZeneca Pharmaceuticals LP USA, under fed&#xD;
      condition in normal, healthy, adult, male and female human subjects in a randomized crossover&#xD;
      study.&#xD;
&#xD;
      The study was conducted with 40 healthy adult subjects. In each study period, a single 40 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 18 days including washout period of 14&#xD;
      days between administrations of study drug in each study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 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 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 6.25, 6.50, 6.75, 7.00, 7.25, 7.50, 7.75, 8.00, 8.50, 9.00, 10.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>2 months</time_frame>
    <description>Sampling Hours: Pre-dose and at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 6.25, 6.50, 6.75, 7.00, 7.25, 7.50, 7.75, 8.00, 8.50, 9.00, 10.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Fed</condition>
  <arm_group>
    <arm_group_label>Lisinopril Tablets 40 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lisinopril Tablets 40 mg of Ipca Laboratories Limited, India</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zestril® (Lisinopril) 40 mg Tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Zestril® (Lisinopril) 40 mg Tablets of AstraZeneca Pharmaceuticals LP USA</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lisinopril Tablets 40 mg</intervention_name>
    <description>40 mg tablet once a day</description>
    <arm_group_label>Lisinopril Tablets 40 mg</arm_group_label>
    <other_name>Test Product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lisinopril</intervention_name>
    <description>40 mg tablet once a day</description>
    <arm_group_label>Zestril® (Lisinopril) 40 mg Tablets</arm_group_label>
    <other_name>Zestril® (Lisinopril) 40 mg Tablets</other_name>
  </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. 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;
          6. No history of significant alcoholism.&#xD;
&#xD;
          7. 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;
          8. Non-smokers were included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known history of hypersensitivity to Lisinopril 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>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>Lisinopril</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/NCT01735344
org study id: Ipca/ARL-10/385
nct id: NCT01735344
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:
      Lisinopril Tablets 40 mg of Ipca Laboratories Limited, India and the corresponding Reference
      Product: Zestril® (Lisinopril) 40 mg Tablets of AstraZeneca Pharmaceuticals LP USA, under fed
      condition in normal, healthy, adult, male and female human subjects in a randomized crossover
      study.

      The study was conducted with 40 healthy adult subjects. In each study period, a single 40 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 18 days including washout period of 14
      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 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 6.25, 6.50, 6.75, 7.00, 7.25, 7.50, 7.75, 8.00, 8.50, 9.00, 10.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose.
measure: AUC
time frame: 2 months
description: Sampling Hours: Pre-dose and at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 6.25, 6.50, 6.75, 7.00, 7.25, 7.50, 7.75, 8.00, 8.50, 9.00, 10.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose.
arm group label: Lisinopril Tablets 40 mg
arm group type: Experimental
description: Lisinopril Tablets 40 mg of Ipca Laboratories Limited, India
arm group label: Zestril® (Lisinopril) 40 mg Tablets
arm group type: Active Comparator
description: Zestril® (Lisinopril) 40 mg Tablets of AstraZeneca Pharmaceuticals LP USA
intervention type: Drug
intervention name: Lisinopril Tablets 40 mg
description: 40 mg tablet once a day
arm group label: Lisinopril Tablets 40 mg
other name: Test Product
intervention type: Drug
intervention name: Lisinopril
description: 40 mg tablet once a day
arm group label: Zestril® (Lisinopril) 40 mg Tablets
other name: Zestril® (Lisinopril) 40 mg Tablets
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: Lisinopril