<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/NCT02254447</url>
  </required_header>
  <id_info>
    <org_study_id>201713</org_study_id>
    <nct_id>NCT02254447</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability Study of Candesartan Cilexetil Under Fasting Conditions</brief_title>
  <official_title>An Open-label, Randomized, Single Dose, Three-way Crossover, Six Sequence Pilot Study to Determine the Relative Bioavailability of Candesartan Cilexetil 16mg From Two Candidate Tablet Formulations of GW615775 Relative to One 16mg Tablet of Reference Candesartan Cilexetil in Healthy Adult Human Subjects Under Fasting Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the relative bioavailability of two candidate tablet formulations&#xD;
      of 16 milligram (mg) Candesartan cilexetil (GW615775) compared with the reference product&#xD;
      ATACAND™ containing 16 mg Candesartan cilexetil in healthy human subjects. This is an&#xD;
      open-label, randomized, single dose, three-way crossover, six sequence study enrolling 18&#xD;
      healthy human subjects to ensure at least 14 subjects complete the study as planned. Each&#xD;
      subject enrolled will participate in all three treatment periods and will be assigned to one&#xD;
      of the six treatment sequences, in accordance with the randomization schedule. The treatment&#xD;
      periods will be separated by a washout period of at least 7 days and no more than 14 days&#xD;
      between dosing occasions. A follow up visit will be conducted 14-21 days post last dosing.&#xD;
      ATACAND is a registered trademark of the AstraZeneca group of companies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2014</start_date>
  <completion_date type="Actual">January 8, 2015</completion_date>
  <primary_completion_date type="Actual">January 8, 2015</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of pharmacokinetic (PK) parameters.</measure>
    <time_frame>PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24, 36 and 48 hours post dose in each treatment period.</time_frame>
    <description>Pharmacokinetic parameters will be measured to estimate the relative bio-availability following administration of two candidate tablet formulations of Candesartan cilexetil relative to reference Candesartan cilexetil tablet. Pharmacokinetic parameters include: maximum observed concentration (Cmax), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinite]), Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC[0-t]).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma PK profile</measure>
    <time_frame>PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24, 36 and 48 hours post dose in each treatment period.</time_frame>
    <description>Pharmacokinetic parameters to be estimated include: time of occurrence of Cmax (Tmax), terminal phase half-life (t1/2) and percentage of AUC(0-infinity) obtained by extrapolation (%AUCex).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital sign assessment as a safety measure</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Vital sign assessment include: blood pressure and pulse rate measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events as a safety measure</measure>
    <time_frame>50 days</time_frame>
    <description>Adverse events will be collected from the start of Study Treatment until the subject's final discharge from study at the end of Treatment Period 3, follow-up call or last outpatient visit, whichever is the latest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory parameter assessment as a safety measure</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Laboratory parameters include: hematology, clinical chemistry, urinalysis and additional parameters.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Sequence ABC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive single dose of treatment A in period 1, treatment B in period 2 and treatment C in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence ACB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive single dose of treatment A in period 1, treatment C in period 2 and treatment B in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence BAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive single dose of treatment B in period 1, treatment A in period 2 and treatment C in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence BCA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive single dose of treatment B in period 1, treatment C in period 2 and treatment A in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence CAB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive single dose of treatment C in period 1, treatment A in period 2 and treatment B in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence CBA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive single dose of treatment C in period 1, treatment B in period 2 and treatment A in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Candesartan Cilexetil in formulation 1</intervention_name>
    <description>Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration</description>
    <arm_group_label>Sequence ABC</arm_group_label>
    <arm_group_label>Sequence ACB</arm_group_label>
    <arm_group_label>Sequence BAC</arm_group_label>
    <arm_group_label>Sequence BCA</arm_group_label>
    <arm_group_label>Sequence CAB</arm_group_label>
    <arm_group_label>Sequence CBA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Candesartan Cilexetil in formulation 2</intervention_name>
    <description>Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration</description>
    <arm_group_label>Sequence ABC</arm_group_label>
    <arm_group_label>Sequence ACB</arm_group_label>
    <arm_group_label>Sequence BAC</arm_group_label>
    <arm_group_label>Sequence BCA</arm_group_label>
    <arm_group_label>Sequence CAB</arm_group_label>
    <arm_group_label>Sequence CBA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATACAND</intervention_name>
    <description>Round, biconvex pink tablets containing Candesartan cilexetil 16 mg for oral administration</description>
    <arm_group_label>Sequence ABC</arm_group_label>
    <arm_group_label>Sequence ACB</arm_group_label>
    <arm_group_label>Sequence BAC</arm_group_label>
    <arm_group_label>Sequence BCA</arm_group_label>
    <arm_group_label>Sequence CAB</arm_group_label>
    <arm_group_label>Sequence CBA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and females aged between 18 and 65 years of age inclusive, at the time of signing&#xD;
             the informed consent.&#xD;
&#xD;
          -  Healthy as determined by the investigator or medically qualified designee based on a&#xD;
             medical evaluation including medical history, physical examination, laboratory tests&#xD;
             and cardiac monitoring.&#xD;
&#xD;
          -  A subject with a clinical abnormality or laboratory parameter(s) which is/are not&#xD;
             specifically listed in the inclusion or exclusion criteria, outside the reference&#xD;
             range for the population being studied may be included only if the investigator in&#xD;
             consultation with the Medical Monitor if required, agree and document that the finding&#xD;
             is unlikely to introduce additional risk factors and will not interfere with the study&#xD;
             procedures.&#xD;
&#xD;
          -  Body weight &gt;= 50 kilograms (kg) and Body Mass Index within the range 19 -24.9&#xD;
             kg/meter (m)^2 (inclusive).&#xD;
&#xD;
          -  Female subject: is eligible to participate if she is not pregnant (as confirmed by a&#xD;
             negative serum human chorionic gonadotrophin test), not lactating, and at least one of&#xD;
             the following conditions applies:&#xD;
&#xD;
        Non-reproductive potential defined as: Pre-menopausal females with documented tubal&#xD;
        ligation, or documented hysteroscopic tubal occlusion procedure with follow-up confirmation&#xD;
        of bilateral tubal occlusion, or hysterectomy, or documented bilateral oophorectomy.&#xD;
&#xD;
        Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a&#xD;
        blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent&#xD;
        with menopause [refer to laboratory reference ranges for confirmatory levels]). Females on&#xD;
        hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required&#xD;
        to use one of the highly effective contraception methods if they wish to continue their HRT&#xD;
        during the study. Otherwise, they must discontinue HRT to allow confirmation of&#xD;
        post-menopausal status prior to study enrolment.&#xD;
&#xD;
        Reproductive potential and agrees to follow one of the options listed below in the&#xD;
        GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in&#xD;
        Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose&#xD;
        of study medication and until [at least five terminal half-lives OR until any continuing&#xD;
        pharmacologic effect has ended, whichever is longer] after the last dose of study&#xD;
        medication and completion of the follow-up visit.&#xD;
&#xD;
        GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP. This list does&#xD;
        not apply to FRP with same sex partners, when this is their preferred and usual lifestyle&#xD;
        or for subjects who are and will continue to be abstinent from penilevaginal intercourse on&#xD;
        a long term and persistent basis:&#xD;
&#xD;
        Contraceptive subdermal implant that meets the effectiveness criteria including a &lt;1% rate&#xD;
        of failure per year, as stated in the product label.&#xD;
&#xD;
        Intrauterine device or intrauterine system that meets the standard operating procedure&#xD;
        (SOP) effectiveness criteria including a &lt;1% rate of failure per year, as stated in the&#xD;
        product label.&#xD;
&#xD;
        Oral Contraceptive, either combined or progestogen alone. Injectable progestogen&#xD;
        Contraceptive vaginal ring Percutaneous contraceptive patches Male partner sterilization&#xD;
        with documentation of azoospermia prior to the female subject's entry into the study, and&#xD;
        this male is the sole partner for that subject Male condom combined with a vaginal&#xD;
        spermicide (foam, gel, film, cream, or suppository) only for the following 3 situations&#xD;
        when there is a very low risk for developmental toxicity: Vaccines, Monoclonal antibodies&#xD;
        when there is no target biology concern, Compounds that have a complete reproductive&#xD;
        toxicology package and, have not shown any signal for developmental toxicity.&#xD;
&#xD;
        The investigator is responsible for ensuring that subjects understand how to properly use&#xD;
        the following methods of contraception. Male subjects with female partners of child bearing&#xD;
        potential must comply with the following contraception requirements from the time of first&#xD;
        dose of study medication until [at least five half-lives of study medication OR for a cycle&#xD;
        of spermatogenesis following five terminal half-lives] after the last dose of study&#xD;
        medication: vasectomy with documentation of azoospermia, male condom plus partner use of&#xD;
        one of the contraceptive options below:&#xD;
&#xD;
        Contraceptive subdermal implant that meets the SOP effectiveness criteria including a &lt;1%&#xD;
        rate of failure per year, as stated in the product label Intrauterine device or&#xD;
        intrauterine system that meets the SOP effectiveness criteria including a &lt;1% rate of&#xD;
        failure per year, as stated in the product label.&#xD;
&#xD;
        Oral Contraceptive, either combined or progestogen alone Injectable progestogen&#xD;
        Contraceptive vaginal ring Percutaneous contraceptive patches&#xD;
&#xD;
          -  Capable of giving written informed consent, which includes compliance with the&#xD;
             requirements and restrictions listed in the consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alanine aminotransferase and bilirubin &gt;1.5x upper limit of normal (ULN) (isolated&#xD;
             bilirubin &gt;1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin&#xD;
             &lt;35%).&#xD;
&#xD;
          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities&#xD;
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).&#xD;
&#xD;
          -  QT interval corrected (QTc) &gt; 450 millisecond (msec).&#xD;
&#xD;
          -  No concomitant medications should be taken by the subject while participating in the&#xD;
             study.&#xD;
&#xD;
          -  History of regular alcohol consumption within 6 months of the study defined as an&#xD;
             average weekly intake of &gt;21 units for males or &gt;14 units for females. One unit is&#xD;
             equivalent to 8grams of alcohol: a half-pint (equivalent to 240 milliliter [mL]) of&#xD;
             beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.&#xD;
&#xD;
          -  Urinary cotinine levels indicative of smoking or history or regular use of tobacco or&#xD;
             nicotine-containing products within 6 months prior to screening.&#xD;
&#xD;
          -  History of sensitivity to heparin or heparin-induced thrombocytopenia.&#xD;
&#xD;
          -  History of sensitivity to any of the study medications, or components thereof or a&#xD;
             history of drug or other allergy that, in the opinion of the investigator or Medical&#xD;
             Monitor, contraindicates their participation.&#xD;
&#xD;
          -  Hypersensitivity to candesartan cilexetil or to any of the excipients.&#xD;
&#xD;
          -  Presence of hepatitis B surface antigen positive hepatitis C antibody test result at&#xD;
             screening or within 3 months prior to first dose of study treatment. For potent&#xD;
             immunosuppressive agents, subjects with presence of hepatitis B core.&#xD;
&#xD;
          -  A positive pre-study drug/alcohol screen.&#xD;
&#xD;
          -  A positive test for human immunodeficiency virus antibody.&#xD;
&#xD;
          -  Where participation in the study would result in donation of blood or blood products&#xD;
             in excess of 500 mL within a 90 day period.&#xD;
&#xD;
          -  The subject has participated in a clinical trial and has received an investigational&#xD;
             current study: 90 days, 5 half-lives or twice the duration of the biological effect of&#xD;
             the investigational product (whichever is longer).&#xD;
&#xD;
          -  Exposure to more than four new chemical entities within 12 months prior to the first&#xD;
             dosing day.&#xD;
&#xD;
          -  Gastrointestinal disease or with gastrointestinal surgical history which can affect&#xD;
             the absorption of the investigational drug.&#xD;
&#xD;
          -  Any symptoms with a systolic blood pressure&lt;95millimeter of mercury.&#xD;
&#xD;
          -  Pregnant females as determined by positive serum human chorionic gonadotrophin test at&#xD;
             screening or prior to dosing.&#xD;
&#xD;
          -  Lactating females.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hyderabad</city>
        <zip>500 013</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>March 8, 2018</last_update_submitted>
  <last_update_submitted_qc>March 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>relative bio-availability</keyword>
  <keyword>fasting</keyword>
  <keyword>GW615775</keyword>
  <keyword>Candesartan cilexetil</keyword>
  <keyword>ATACAND</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candesartan</mesh_term>
    <mesh_term>Candesartan cilexetil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>201713</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201713</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201713</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201713</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201713</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201713</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201713</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT02254447
org study id: 201713
nct id: NCT02254447
lead sponsor: 
has dmc: No
This study will investigate the relative bioavailability of two candidate tablet formulations
      of 16 milligram (mg) Candesartan cilexetil (GW615775) compared with the reference product
      ATACAND™ containing 16 mg Candesartan cilexetil in healthy human subjects. This is an
      open-label, randomized, single dose, three-way crossover, six sequence study enrolling 18
      healthy human subjects to ensure at least 14 subjects complete the study as planned. Each
      subject enrolled will participate in all three treatment periods and will be assigned to one
      of the six treatment sequences, in accordance with the randomization schedule. The treatment
      periods will be separated by a washout period of at least 7 days and no more than 14 days
      between dosing occasions. A follow up visit will be conducted 14-21 days post last dosing.
      ATACAND is a registered trademark of the AstraZeneca group of companies.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Composite of pharmacokinetic (PK) parameters.
time frame: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24, 36 and 48 hours post dose in each treatment period.
description: Pharmacokinetic parameters will be measured to estimate the relative bio-availability following administration of two candidate tablet formulations of Candesartan cilexetil relative to reference Candesartan cilexetil tablet. Pharmacokinetic parameters include: maximum observed concentration (Cmax), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinite]), Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC[0-t]).
measure: Plasma PK profile
time frame: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24, 36 and 48 hours post dose in each treatment period.
description: Pharmacokinetic parameters to be estimated include: time of occurrence of Cmax (Tmax), terminal phase half-life (t1/2) and percentage of AUC(0-infinity) obtained by extrapolation (%AUCex).
measure: Vital sign assessment as a safety measure
time frame: Up to 30 days
description: Vital sign assessment include: blood pressure and pulse rate measurements.
measure: Number of subjects with adverse events as a safety measure
time frame: 50 days
description: Adverse events will be collected from the start of Study Treatment until the subject's final discharge from study at the end of Treatment Period 3, follow-up call or last outpatient visit, whichever is the latest.
measure: Laboratory parameter assessment as a safety measure
time frame: Up to 30 days
description: Laboratory parameters include: hematology, clinical chemistry, urinalysis and additional parameters.
arm group label: Sequence ABC
arm group type: Experimental
description: Subjects in this arm will receive single dose of treatment A in period 1, treatment B in period 2 and treatment C in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.
arm group label: Sequence ACB
arm group type: Experimental
description: Subjects in this arm will receive single dose of treatment A in period 1, treatment C in period 2 and treatment B in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.
arm group label: Sequence BAC
arm group type: Experimental
description: Subjects in this arm will receive single dose of treatment B in period 1, treatment A in period 2 and treatment C in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.
arm group label: Sequence BCA
arm group type: Experimental
description: Subjects in this arm will receive single dose of treatment B in period 1, treatment C in period 2 and treatment A in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.
arm group label: Sequence CAB
arm group type: Experimental
description: Subjects in this arm will receive single dose of treatment C in period 1, treatment A in period 2 and treatment B in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.
arm group label: Sequence CBA
arm group type: Experimental
description: Subjects in this arm will receive single dose of treatment C in period 1, treatment B in period 2 and treatment A in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.
intervention type: Drug
intervention name: Candesartan Cilexetil in formulation 1
description: Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration
arm group label: Sequence ABC
arm group label: Sequence ACB
arm group label: Sequence BAC
arm group label: Sequence BCA
arm group label: Sequence CAB
arm group label: Sequence CBA
intervention type: Drug
intervention name: Candesartan Cilexetil in formulation 2
description: Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration
arm group label: Sequence ABC
arm group label: Sequence ACB
arm group label: Sequence BAC
arm group label: Sequence BCA
arm group label: Sequence CAB
arm group label: Sequence CBA
intervention type: Drug
intervention name: ATACAND
description: Round, biconvex pink tablets containing Candesartan cilexetil 16 mg for oral administration
arm group label: Sequence ABC
arm group label: Sequence ACB
arm group label: Sequence BAC
arm group label: Sequence BCA
arm group label: Sequence CAB
arm group label: Sequence CBA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: India
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Candesartan
mesh term: Candesartan cilexetil
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
study doc: 
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