<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/NCT01712126</url>
  </required_header>
  <id_info>
    <org_study_id>IRHY-T300-PVFD-1</org_study_id>
    <nct_id>NCT01712126</nct_id>
  </id_info>
  <brief_title>Crossover Bioequivalence Study of Irbesartan Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions</brief_title>
  <official_title>A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Irbesartan / Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roxane Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West-Ward Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'&#xD;
      Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fed conditions&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2007</start_date>
  <completion_date type="Actual">September 2007</completion_date>
  <primary_completion_date type="Actual">September 2007</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bioequivalence determined by statistical comparison Cmax</measure>
    <time_frame>Blood samples will be collected in Vacutainers containing K3EDTA (1 x 7 mL) before dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Irbesartan and Hydrochlorothiazide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 mg and 25 mg tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Avalide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>irbesartan 300 mg and hydrochlorothiazide 25 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irbesartan and Hydrochlorothiazide</intervention_name>
    <arm_group_label>Irbesartan and Hydrochlorothiazide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Avalide</intervention_name>
    <arm_group_label>Avalide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects between the ages of 18 and 45 years (inclusive).&#xD;
&#xD;
          2. Voluntary consent to participate in the study.&#xD;
&#xD;
          3. Body Mass Index (BMI) between 18 and 30 (inclusive).&#xD;
&#xD;
          4. Female subjects of childbearing potential - not surgically sterile or at least 2 years&#xD;
             postmenopausal - must agree to utilize one of the following forms of contraception&#xD;
             from screening through completion of the study: abstinence, hormonal (oral, implant,&#xD;
             transdermal, or injection) for at least 3 months prior to the first dose of the study,&#xD;
             barrier (condom with spermicide, diaphragm with spermicide), IUD, or vasectomized&#xD;
             partner (6 months minimum).&#xD;
&#xD;
          5. No clinically significant abnormal findings on the physical examination, medical&#xD;
             history, or clinical laboratory results during screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A history of clinically significant gastrointestinal, renal, hepatic, neurologic,&#xD;
             hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or&#xD;
             cardiovascular disease or any other condition which, in the opinion of the&#xD;
             Investigator, would jeopardize the safety of the subject or impact the validity of the&#xD;
             study results.&#xD;
&#xD;
          2. A history of allergic or adverse responses to irbesartan and hydrochlorothiazide, or&#xD;
             any comparable or similar product.&#xD;
&#xD;
          3. Subjects who (for whatever reason) have been on an abnormal diet or have had&#xD;
             substantial changes in eating habits within 30 days prior to study initiation.&#xD;
&#xD;
          4. Subjects must not have made a blood donation of one pint or more within 30 days prior&#xD;
             to study initiation.&#xD;
&#xD;
          5. Subjects must not have made a plasma donation within 14 days of study initiation.&#xD;
&#xD;
          6. Participation in a clinical trial within 30 days prior to study initiation.&#xD;
&#xD;
          7. Use of any over-the-counter (OTC) medication, including vitamins, herbal products, and&#xD;
             dietary supplements, within 7 days prior to or during the study.&#xD;
&#xD;
          8. Use of any prescription medication within 7 days prior to or during the study, with&#xD;
             the exception of hormonal contraceptives for women of childbearing potential, or&#xD;
             hormone replacement therapy.&#xD;
&#xD;
          9. Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines,&#xD;
             cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem,&#xD;
             ketoconazole, MAOI, antidepressants, neuroleptics, verapamil, quinidine, erythromycin,&#xD;
             etc., within 30 days prior to or during the study.&#xD;
&#xD;
         10. Smoking or use of tobacco products within 6 months prior to or during the study.&#xD;
&#xD;
         11. Female subjects who are lactating.&#xD;
&#xD;
         12. Positive serum pregnancy test for female subjects.&#xD;
&#xD;
         13. Positive blood screen for HIV, Hepatitis B or Hepatitis C.&#xD;
&#xD;
         14. Positive screen for alcohol or drugs of abuse, and history or presence of alcoholism&#xD;
             or drug abuse within 6 months prior to the study start.&#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>Jolene K Berg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>January 19, 2018</last_update_submitted>
  <last_update_submitted_qc>January 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</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>Hypertension</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrochlorothiazide</mesh_term>
    <mesh_term>Irbesartan</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/NCT01712126
org study id: IRHY-T300-PVFD-1
nct id: NCT01712126
lead sponsor: 
has dmc: No
The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fed conditions
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: bioequivalence determined by statistical comparison Cmax
time frame: Blood samples will be collected in Vacutainers containing K3EDTA (1 x 7 mL) before dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing.
arm group label: Irbesartan and Hydrochlorothiazide
arm group type: Experimental
description: 300 mg and 25 mg tablet
arm group label: Avalide
arm group type: Active Comparator
description: irbesartan 300 mg and hydrochlorothiazide 25 mg
intervention type: Drug
intervention name: Irbesartan and Hydrochlorothiazide
arm group label: Irbesartan and Hydrochlorothiazide
intervention type: Drug
intervention name: Avalide
arm group label: Avalide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jolene K Berg, MD
role: Principal Investigator
affiliation: Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Malnutrition
mesh term: Hydrochlorothiazide
mesh term: Irbesartan