<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/NCT02197442</url>
  </required_header>
  <id_info>
    <org_study_id>044-14</org_study_id>
    <nct_id>NCT02197442</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Valsartan 320mg Tablets Under Fasting Conditions</brief_title>
  <official_title>An Open Label, Balanced, Randomized, Two-treatment, Four-period, Two-sequence, Single Oral Dose, Crossover, Fully Replicate Bioequivalence Study of Two Formulations of Valsartan 320 mg Tablet in Healthy, Adult, Human Subjects Under Fasting 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, four-period, two sequence,&#xD;
      single oral dose, crossover, fully replicate bioequivalence study of two formulations of&#xD;
      Valsartan 320 mg under fasting conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tablet in healthy, adult human subjects under fasting condition, with a screening period of&#xD;
      28 days prior to dose administration in Period-I. In each study period, twenty-four (24)&#xD;
      blood samples, including two (02) predose blood samples, each of 02 mL were collected from&#xD;
      each subject except for the discontinued / withdrawn subjects to analyze the pharmacokinetic&#xD;
      profile of the test as well as the reference product.&#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">36</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>
    <arm_group_label>Reference</arm_group_label>
    <arm_group_label>Test</arm_group_label>
    <other_name>320mg tablets</other_name>
  </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 Ahmedabad 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. Inability to remain in an upright position at the time of dosing.&#xD;
&#xD;
          7. 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;
          8. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or&#xD;
             NSAIDs induced urticaria.&#xD;
&#xD;
          9. 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;
         10. Smokers, who smoke 10 or more than 10 cigarettes/day or inability to abstain from&#xD;
             smoking during the study.&#xD;
&#xD;
         11. The presence of clinically significant abnormal laboratory values during screening.&#xD;
&#xD;
         12. Use of any recreational drugs or history of drug addiction or testing positive in pre&#xD;
             study drug scans.&#xD;
&#xD;
         13. History or presence of psychiatric disorders.&#xD;
&#xD;
         14. A history of difficulty in donating blood.&#xD;
&#xD;
         15. 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;
         16. A positive hepatitis screen including hepatitis B surface antigen and/or HCV&#xD;
             antibodies.&#xD;
&#xD;
         17. A positive test result for HIV antibody.&#xD;
&#xD;
         18. 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;
         19. Consumption of grapefruit or grapefruit products within 48 hours prior to dosing.&#xD;
&#xD;
         20. 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>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380 061</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>
  <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/NCT02197442
org study id: 044-14
nct id: NCT02197442
lead sponsor: 
has dmc: No
The study was an open label, balanced, randomized, two-treatment, four-period, two sequence,
      single oral dose, crossover, fully replicate bioequivalence study of two formulations of
      Valsartan 320 mg under fasting conditions.
Tablet in healthy, adult human subjects under fasting condition, with a screening period of
      28 days prior to dose administration in Period-I. In each study period, twenty-four (24)
      blood samples, including two (02) predose blood samples, 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 product.

      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
arm group label: Reference
arm group label: Test
other name: 320mg tablets
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: Valsartan