<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/NCT02197494</url>
  </required_header>
  <id_info>
    <org_study_id>042-14</org_study_id>
    <nct_id>NCT02197494</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Valsartan 320mg Tablets Under Fed Conditions</brief_title>
  <official_title>An Open Label, Balanced, Randomized, Two-treatment, Two Period, Two-sequence, Single Oral Dose, Crossover, Bioequivalence Study of Two Formulations of Valsartan 320mg Tablet in Healthy, Adult, Human Subjects Under Fed Condition.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ranbaxy Laboratories Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ranbaxy Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,&#xD;
      single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg&#xD;
      under fed conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After an overnight fast of at least 10 hours, the subjects were served a USFDA recommended&#xD;
      high fat high calorie non-vegetarian breakfast, which they consumed within 30 minutes.&#xD;
&#xD;
      A single oral dose (320 mg) of either the test or the reference product was administered to&#xD;
      the subjects at 30 ± 2 minutes minutes after serving the USFDA recommended high fat high&#xD;
      calorie non-vegetarian breakfast. The IMP was administered in sitting posture with 240 mL of&#xD;
      drinking water at ambient temperature. The IMP administration was as per the randomization&#xD;
      schedule and under open-label condition.&#xD;
&#xD;
      A total of twenty-six (26) blood samples including pre-dose sample (duplicate), each of 02&#xD;
      mL, were collected from each subject except for the discontinued / withdrawn subjects to&#xD;
      analyze the pharmacokinetic profile of the test as well as the reference drug.&#xD;
&#xD;
      The pharmacokinetic parameters were calculated from the drug concentration vs. time profile&#xD;
      by non-compartmental model using WinNonlin Professional Software Version 5.3 (Pharsight&#xD;
      Corporation, USA) for Valsartan. Statistical comparison of the pharmacokinetic parameters of&#xD;
      the two formulations was carried out using PROC MIXED of SAS® Version 9.3 (SAS Institute&#xD;
      Inc., USA) to assess the bioequivalence of both the formulations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Valsartan</measure>
    <time_frame>0-36 hrs</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Valsartan Tablets USP 320 mg DIVIS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diovan® (Valsartan) 320 Tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Valsartan</intervention_name>
    <description>320mg tablets</description>
    <arm_group_label>Reference</arm_group_label>
    <arm_group_label>Test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy, adult, human volunteers between 18 to 45 years of age (both inclusive) living&#xD;
             in and around Mumbai city or western part of India.&#xD;
&#xD;
          2. Having a Body Mass Index (BMI) between 18.5 - 24.9 (both inclusive), calculated as&#xD;
             weight in kg/height in meter2.&#xD;
&#xD;
          3. Not having any significant disease in medical history or clinically significant&#xD;
             abnormal findings during screening, medical history, physical examination, laboratory&#xD;
             evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.&#xD;
&#xD;
          4. Able to understand and comply with the study procedures, in the opinion of the&#xD;
             investigator.&#xD;
&#xD;
          5. Able to give voluntary written informed consent for participation in the trial.&#xD;
&#xD;
          6. In case of female subjects:&#xD;
&#xD;
               -  Surgically sterilized at least 6 months prior to study participation; Or&#xD;
&#xD;
               -  If of child bearing potential is willing to use a suitable and effective double&#xD;
                  barrier contraceptive method or intra uterine device during the study.&#xD;
&#xD;
        And&#xD;
&#xD;
        • Pregnancy test must be negative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known hypersensitivity or idiosyncratic reaction to valsartan or any of the&#xD;
             formulation excipients or any related drug.&#xD;
&#xD;
          2. History or presence of any disease or condition which might compromise the&#xD;
             haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular,&#xD;
             immunological, dermatological, gastrointestinal or any other body system.&#xD;
&#xD;
          3. Sitting blood pressure less than 110 /70 mm Hg and pulse rate less than 60 or more&#xD;
             than 100 beats per minute at the time of screening.&#xD;
&#xD;
          4. Presence of orthostatic hypotension.&#xD;
&#xD;
          5. If the QTc interval were to be more than 450 ms on ECG measurement at the time of&#xD;
             screening.&#xD;
&#xD;
          6. Ingestion of a medicine (including herbal remedies) at any time within 14 days before&#xD;
             dosing in period-I. In any such case subject selection were at the discretion of the&#xD;
             Principal Investigator.&#xD;
&#xD;
          7. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or&#xD;
             NSAIDs induced urticaria.&#xD;
&#xD;
          8. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol&#xD;
             consumption of more than 14 standard drinks per week for men and more than 7 standard&#xD;
             drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of&#xD;
             wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or&#xD;
             consumption of alcohol or alcoholic products within 48 hours prior to receiving study&#xD;
             medicine.&#xD;
&#xD;
          9. Smokers, who smoke 10 or more than 10 cigarettes/day or inability to abstain from&#xD;
             smoking during the study.&#xD;
&#xD;
         10. The presence of clinically significant abnormal laboratory values during screening.&#xD;
&#xD;
         11. Use of any recreational drugs or history of drug addiction or testing positive in pre&#xD;
             study drug scans.&#xD;
&#xD;
         12. History or presence of psychiatric disorders.&#xD;
&#xD;
         13. A history of difficulty in donating blood.&#xD;
&#xD;
         14. Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal&#xD;
             product or participation in a drug research study within a period of 90 days prior to&#xD;
             the first dose of study medication. Elimination half-life of the study drug should be&#xD;
             taken into consideration for inclusion of the subject in the study.&#xD;
&#xD;
             Note: In case the blood loss is ≤ 200 mL; subject may be dosed 60 days after blood&#xD;
             donation or last sample of the previous study.&#xD;
&#xD;
         15. A positive hepatitis screen including hepatitis B surface antigen and/or HCV&#xD;
             antibodies.&#xD;
&#xD;
         16. A positive test result for HIV antibody.&#xD;
&#xD;
         17. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to&#xD;
             receiving the study medicine in period-I. In any such case subject selection were at&#xD;
             the discretion of the Principal Investigator.&#xD;
&#xD;
         18. Consumption of grapefruit or grapefruit products within 48 hours prior to dosing.&#xD;
&#xD;
         19. Nursing mothers (females).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lambda Therapeutic Research Ltd.</name>
      <address>
        <city>Navi Mumbai</city>
        <state>Maharashtra</state>
        <zip>400 614</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://clinicalstudies.ranbaxy.com</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://dailymed.nlm.nih.gov/dailymed/about.cfm</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</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>Valsartan</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/NCT02197494
org study id: 042-14
nct id: NCT02197494
lead sponsor: 
has dmc: No
The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,
      single oral dose, crossover, bioequivalence study of two formulations of Valsartan 320 mg
      under fed conditions.
After an overnight fast of at least 10 hours, the subjects were served a USFDA recommended
      high fat high calorie non-vegetarian breakfast, which they consumed within 30 minutes.

      A single oral dose (320 mg) of either the test or the reference product was administered to
      the subjects at 30 ± 2 minutes minutes after serving the USFDA recommended high fat high
      calorie non-vegetarian breakfast. The IMP was administered in sitting posture with 240 mL of
      drinking water at ambient temperature. The IMP administration was as per the randomization
      schedule and under open-label condition.

      A total of twenty-six (26) blood samples including pre-dose sample (duplicate), each of 02
      mL, were collected from each subject except for the discontinued / withdrawn subjects to
      analyze the pharmacokinetic profile of the test as well as the reference drug.

      The pharmacokinetic parameters were calculated from the drug concentration vs. time profile
      by non-compartmental model using WinNonlin Professional Software Version 5.3 (Pharsight
      Corporation, USA) for Valsartan. Statistical comparison of the pharmacokinetic parameters of
      the two formulations was carried out using PROC MIXED of SAS® Version 9.3 (SAS Institute
      Inc., USA) to assess the bioequivalence of both the formulations.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Valsartan
time frame: 0-36 hrs
arm group label: Test
arm group type: Experimental
description: Valsartan Tablets USP 320 mg DIVIS
arm group label: Reference
arm group type: Active Comparator
description: Diovan® (Valsartan) 320 Tablets
intervention type: Drug
intervention name: Valsartan
description: 320mg tablets
arm group label: Reference
arm group label: Test
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: India
url: http://clinicalstudies.ranbaxy.com
description: Related Info
url: http://dailymed.nlm.nih.gov/dailymed/about.cfm
description: Related Info
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Valsartan