<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/NCT01710995</url>
  </required_header>
  <id_info>
    <org_study_id>ZEG-02/2010 (BE)</org_study_id>
    <nct_id>NCT01710995</nct_id>
  </id_info>
  <brief_title>A Three-Period Study to Investigate the Relative Bioavailability and Pharmacodynamic Profiles of a Zegerid 20mg Capsule, Zegerid 20mg Powder for Oral Suspension and Losec 20mg Capsule in Healthy Adult Volunteers Under Fasting Conditions</brief_title>
  <official_title>A Randomised, Three-Period, Single Dose, Open-Label, Crossover Study to Investigate the Relative Bioavailability and Pharmacodynamic Profiles of a Zegerid 20mg Capsule, Zegerid 20mg Powder for Oral Suspension and Losec 20mg Capsule in Healthy Adult Volunteers Under Fasting Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norgine</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norgine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder&#xD;
      and Losec 20mg capsules in healthy volunteers under fasting conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">February 2011</completion_date>
  <primary_completion_date type="Actual">November 2010</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>Bioavailability - Area under Curve of pH at 2 hours</measure>
    <time_frame>2 hours</time_frame>
    <description>To assess the relative bioavailability of two immediate release formulations of omeprazole/sodium carbonate (Zegerid 20mg capsule and Zegerid 20mg powder for oral suspension)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics - Area under Curve of pH at 2 hours</measure>
    <time_frame>2 hours</time_frame>
    <description>To assess the relative pharmacodynamic profiles of two immediate release formulations of omeprazole/sodium bicarbonate (Zegerid® 20mg capsule and Zegerid® 20mg powder for oral suspension).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability of study formulations using measurements of Cmax, tmax and t1/2</measure>
    <time_frame>pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose</time_frame>
    <description>To assess the safety and tolerability of these three formulations after single dose oral administration. To include measurements of Cmax, tmax and t1/2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bioavailability - measurement of pH over time</measure>
    <time_frame>0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours</time_frame>
    <description>To assess the relative bioavailability of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg capsule) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state. AUC of pH and % of time for pH to raise above 4 (0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bioavailability - measurement of pH over time</measure>
    <time_frame>0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours</time_frame>
    <description>To assess the relative bioavailability of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg powder for oral suspension) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state. AUC of pH and % of time for pH to raise above 4 (0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Measurements of Cmax, Tmax and t1/2</measure>
    <time_frame>Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose</time_frame>
    <description>To assess the relative pharmacodynamic profiles of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg capsule) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic measurements of Cmax, Tmax and t1/2</measure>
    <time_frame>Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose</time_frame>
    <description>To assess the relative pharmacodynamic profiles of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg powder for oral suspension) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Acid Reflux</condition>
  <condition>Gastro Oesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>Zegerid 20mg capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Zegerid 20mg capsule (20mg omeprazole and 1100mg sodium carbonate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zegerid 20mg powder for oral suspension</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Zegerid 20mg powder for oral suspension (20mg omeprazole and 1680mg sodium bicarbonate)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Losec 20mg capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Losec 20mg capsule (20mg omeprazole)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zegerid</intervention_name>
    <arm_group_label>Zegerid 20mg capsule</arm_group_label>
    <arm_group_label>Zegerid 20mg powder for oral suspension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Losec</intervention_name>
    <arm_group_label>Losec 20mg capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult male or female volunteers aged 18 - 45 years.&#xD;
&#xD;
          -  Non-smokers from three months before receiving the first dose and for the duration of&#xD;
             the study, confirmed by negative urinary cotinine test at screening and check-in.&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 18.0 and ≤ 27.9 kg/m2.&#xD;
&#xD;
          -  Able to voluntarily provide written informed consent to participate in the study.&#xD;
&#xD;
          -  Must understand the purposes and risks of the study and agree to follow the&#xD;
             restrictions and schedule of procedures as defined in the protocol.&#xD;
&#xD;
          -  Able and willing to have a nasogastric tube/probe inserted.&#xD;
&#xD;
          -  Females must be post-menopausal (for at least one year and confirmed by serum FSH at&#xD;
             screening), surgically sterile, practicing true sexual abstinence or using an&#xD;
             acceptable form of effective contraception throughout the study from the following&#xD;
             list: contraceptive implants, injectables, oral contraceptives, intrauterine system&#xD;
             (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method&#xD;
             (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository.&#xD;
&#xD;
          -  Hormonal and IUD methods of contraception must be established for a period of three&#xD;
             months prior to dosing and cannot be changed or altered during the study.&#xD;
&#xD;
          -  Females of childbearing potential must have a negative pregnancy test at screening and&#xD;
             check-in.&#xD;
&#xD;
          -  Must be willing to consent to have data entered into The Over Volunteering Prevention&#xD;
             System (TOPS).&#xD;
&#xD;
          -  The volunteer's primary care physician must confirm that there is nothing in their&#xD;
             medical history that would preclude their enrolment into this clinical study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive for HIV, hepatitis B or hepatitis C.&#xD;
&#xD;
          -  History or presence of significant cardiovascular, pulmonary, hepatic, renal,&#xD;
             haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or&#xD;
             psychiatric disease as determined by the Investigator.&#xD;
&#xD;
          -  History of gastric or duodenal ulcer.&#xD;
&#xD;
          -  History of hiatus hernia.&#xD;
&#xD;
          -  Significant history of reflux symptoms on clinical judgement.&#xD;
&#xD;
          -  Diagnosis of conditions likely to result in a hypersecretory gastric acid state e.g.&#xD;
             Zollinger-Ellison Syndrome.&#xD;
&#xD;
          -  Positive serology test result for H. pylori at screening.&#xD;
&#xD;
          -  Clinically significant deviated nasal septum or other nasopharyngeal obstruction, or&#xD;
             inability to tolerate or site a nasogastric tube at screening.&#xD;
&#xD;
          -  Hypersensitivity or any other contraindication to Zegerid® or Losec®.&#xD;
&#xD;
          -  History or presence of any clinically significant drug allergy.&#xD;
&#xD;
          -  Female subjects who are pregnant or lactating.&#xD;
&#xD;
          -  Laboratory values at screening which are deemed to be clinically significant as&#xD;
             determined by the Investigator.&#xD;
&#xD;
          -  Any clinically relevant history of drug or alcohol abuse.&#xD;
&#xD;
          -  Volunteers who, in the opinion of the Investigator, are unsuitable for participation&#xD;
             in the study.&#xD;
&#xD;
          -  Participation in a clinical drug study during the 90 days preceding the initial dose&#xD;
             of study medication.&#xD;
&#xD;
          -  Any significant illness during the screening period preceding the initial dose of&#xD;
             study medication.&#xD;
&#xD;
          -  Donation of blood or blood products within 90 days prior to study drug administration,&#xD;
             or at any time during the study, except as required by this protocol.&#xD;
&#xD;
          -  Consumption of alcoholic beverages or xanthine-containing products within 24 hours&#xD;
             before confinement or during study confinement.&#xD;
&#xD;
          -  Consumption of cruciferous vegetables or chargrilled foods within 48 hours before&#xD;
             confinement or during study confinement.&#xD;
&#xD;
          -  Consumption of grapefruit or grapefruit juice from seven days before confinement and&#xD;
             until the end of the study.&#xD;
&#xD;
          -  Use of any prescription or over-the-counter medication (including vitamins, herbal and&#xD;
             mineral supplements) within 30 days before study drug administration, or any general&#xD;
             anaesthetic during the three months before study drug administration, and until the&#xD;
             end of the study, with the exception of Investigator-approved hormonal contraceptives,&#xD;
             HRT and occasional paracetamol.&#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>Jerome Hanna, MB BCH MRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bio-Kinetic Europe, Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bio-Kinetic Europe Limited, 14 Great Victoria Street, Belfast BT2 7BA</name>
      <address>
        <city>Belfast</city>
        <zip>BT2 7BA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 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>Gastroesophageal Reflux</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omeprazole, sodium bicarbonate drug combination</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>February 13, 2013</submitted>
    <returned>March 15, 2013</returned>
    <submitted>June 3, 2013</submitted>
    <returned>August 27, 2013</returned>
  </pending_results>
  <!-- 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/NCT01710995
org study id: ZEG-02/2010 (BE)
nct id: NCT01710995
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the effectiveness of Zegerid 20mg capsules and powder
      and Losec 20mg capsules in healthy volunteers under fasting conditions.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bioavailability - Area under Curve of pH at 2 hours
time frame: 2 hours
description: To assess the relative bioavailability of two immediate release formulations of omeprazole/sodium carbonate (Zegerid 20mg capsule and Zegerid 20mg powder for oral suspension)
measure: Pharmacodynamics - Area under Curve of pH at 2 hours
time frame: 2 hours
description: To assess the relative pharmacodynamic profiles of two immediate release formulations of omeprazole/sodium bicarbonate (Zegerid® 20mg capsule and Zegerid® 20mg powder for oral suspension).
measure: Safety and tolerability of study formulations using measurements of Cmax, tmax and t1/2
time frame: pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
description: To assess the safety and tolerability of these three formulations after single dose oral administration. To include measurements of Cmax, tmax and t1/2
measure: Bioavailability - measurement of pH over time
time frame: 0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours
description: To assess the relative bioavailability of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg capsule) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state. AUC of pH and % of time for pH to raise above 4 (0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours)
measure: Bioavailability - measurement of pH over time
time frame: 0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours
description: To assess the relative bioavailability of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg powder for oral suspension) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state. AUC of pH and % of time for pH to raise above 4 (0.5, 1, 1.5, 3, 4, 8, 12, 16 and 24 hours)
measure: Pharmacodynamic Measurements of Cmax, Tmax and t1/2
time frame: Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
description: To assess the relative pharmacodynamic profiles of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg capsule) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state.
measure: Pharmacodynamic measurements of Cmax, Tmax and t1/2
time frame: Pre-dose on day 1, and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
description: To assess the relative pharmacodynamic profiles of an immediate release formulation of omeprazole/sodium bicarbonate (Zegerid 20mg powder for oral suspension) and a delayed-release omeprazole capsule (Losec 20mg) after single dose oral administration in a fasted state
arm group label: Zegerid 20mg capsule
arm group type: Active Comparator
description: Zegerid 20mg capsule (20mg omeprazole and 1100mg sodium carbonate
arm group label: Zegerid 20mg powder for oral suspension
arm group type: Active Comparator
description: Zegerid 20mg powder for oral suspension (20mg omeprazole and 1680mg sodium bicarbonate)
arm group label: Losec 20mg capsule
arm group type: Active Comparator
description: Losec 20mg capsule (20mg omeprazole)
intervention type: Drug
intervention name: Zegerid
arm group label: Zegerid 20mg capsule
arm group label: Zegerid 20mg powder for oral suspension
intervention type: Drug
intervention name: Losec
arm group label: Losec 20mg capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jerome Hanna, MB BCH MRCS
role: Principal Investigator
affiliation: Bio-Kinetic Europe, Ltd.
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Omeprazole, sodium bicarbonate drug combination
submitted: February 13, 2013
returned: March 15, 2013
submitted: June 3, 2013
returned: August 27, 2013