<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/NCT03772158</url>
  </required_header>
  <id_info>
    <org_study_id>CCSURA000499</org_study_id>
    <nct_id>NCT03772158</nct_id>
  </id_info>
  <brief_title>Cetirizine Chewable Bioequivalence and Food Effect Study</brief_title>
  <official_title>A Randomized, Single-Dose, Four-Treatment Crossover Bioequivalence and Food Effect Study of Test Formulation of Cetirizine 10mg Chewable Tablets Versus Two Marketed Cetirizine 10mg Immediate Release Tablets.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Consumer Inc., McNeil Consumer Healthcare Division</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Consumer and Personal Products Worldwide</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine and compare the amount of study drug that gets into&#xD;
      your blood after the administration of each of the three formulations of cetirizine under&#xD;
      different conditions. Another objective of this study is to evaluate the effect of food on&#xD;
      the amount of study drug that gets into your blood after the administration of the&#xD;
      investigational formulation. Other objectives of this study are to determine the sensory&#xD;
      experience and ease of swallowing the investigational formulation, as well as to determine&#xD;
      the safety of test and reference formulations of cetirizine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to establish bioequivalence of a cetirizine 10 mg chewable&#xD;
      tablet manufactured at Johnson &amp; Johnson Consumer Inc. (McNeil LLC) with two commercially&#xD;
      marketed cetirizine 10 mg immediate release (IR) tablets (ZYRTEC®, US reference) and&#xD;
      (Australian/EU reference), establish bioequivalence between the two commercial products&#xD;
      (ZYRTEC®, US reference and REACTINE®, Australian/EU reference), and to evaluate the effect of&#xD;
      food on bioavailability of the cetirizine 10 mg chewable tablet compared to the&#xD;
      bioavailability of cetirizine 10 mg chewable tablet administrated with water only. In&#xD;
      addition, subject's sensory experience and ease of swallowing of the test product will be&#xD;
      assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Actual">February 3, 2019</completion_date>
  <primary_completion_date type="Actual">February 3, 2019</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>
    <intervention_model_description>This is a randomized, single-dose, four-treatment crossover bioequivalence and food effect study of Cetirizine Chewable Tablets versus ZYRTEC® Immediate Release (IR) Tablets (US reference) and REACTINE® IR Tablets (EU and Australian marketed reference product).&#xD;
The study will be conducted in two parts. Part 1 of the study will have a randomized, four way crossover study design in which 40 healthy subjects, ages 18 to 55 years, will be randomized to four sequences of Treatments A, B, D and E over consecutive periods. No less than approximately 40% of either gender will be represented in the study population. Part 2 of the study will assess a potential food effect in which all subjects will be administered Treatment C in the fifth period.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blinding of the test and reference products to study subjects is not feasible, because the products are different dosage forms (chewable tablets and IR tablets) and administered in different ways (with or without water and fasted or fed). Personnel conducting the bioanalyses of samples will not know the treatment sequence. The randomization code will not be available to them until the analytical tables have been finalized and audited by the Algorithme Pharma (An Altasciences Company) Quality Assurance (QA) department.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The maximum observed plasma concentration (Cmax) of cetirizine</measure>
    <time_frame>At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.</time_frame>
    <description>The maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The area under the plasma concentration versus time curves to the last measurable concentration (AUCt)</measure>
    <time_frame>At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.</time_frame>
    <description>Area under the plasma concentration versus time curve from start of drug administration until last measurable concentration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve extrapolated to infinity</measure>
    <time_frame>At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.</time_frame>
    <description>Area under the plasma concentration-time curve extrapolated to infinity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time point at which the maximum concentration of cetirizine is observed (Tmax).</measure>
    <time_frame>At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.</time_frame>
    <description>The time point at which the maximum concentration of cetirizine occurs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The terminal elimination half-life (T1/2) of cetirizine in plasma</measure>
    <time_frame>At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.</time_frame>
    <description>The time it takes for the cetirizine plasma concentration to fall to half of its original value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The terminal elimination rate constant (lambda z) for cetirizine in plasma.</measure>
    <time_frame>At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.</time_frame>
    <description>The rate at which the drug is removed from the body system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess subject's sensory experience and ease of swallowing of the test product</measure>
    <time_frame>Assessed one minute after dosing, and preferably completed within 15 minutes of dosing for treatments A, B and C</time_frame>
    <description>A questionaire with 5 product sensory questions for study subjects to answer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events.</measure>
    <time_frame>Approximately 3 months. From signed informed consent until 30 days after last treatment administration.</time_frame>
    <description>An adverse event is any untoward medical occurrence in a subject after they have signed an informed consent for a trial involving an investigational product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The extrapolated part of the area under the plasma concentration versus time curve of cetirizine</measure>
    <time_frame>Extrapolated from 12 hours after start of drug administration until 48 hours</time_frame>
    <description>The area under the plasma concentration versus time curve from 12 hours after start of drug administration until 48 hours after start of drug administration.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Allergy</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast and followed with 240 mL ambient water. Subjects will be instructed to chew the tablet completely before swallowing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast without water. Subjects will be instructed to chew the tablet completely before swallowing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast and 30 minutes after the start of the standard high-fat breakfast and followed with 240 mL ambient water. Subjects will be instructed to chew the tablet completely before swallowing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of currently marketed US 10 mg cetirizine as immediate release tablet (ZYRTEC®), administered orally after a 10-hour overnight fast and followed with 240 mL ambient water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment E</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of currently marketed EU/Australian 10 mg cetirizine film coated tablet (REACTINE®) administered orally after a 10-hour overnight fast and followed with 240 mL ambient water.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetirizine 10mg</intervention_name>
    <description>Chewable tablet</description>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_label>Treatment C</arm_group_label>
    <other_name>Test product</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetirizine 10 mg</intervention_name>
    <description>Immediate Release Tablet</description>
    <arm_group_label>Treatment D</arm_group_label>
    <other_name>ZYRTEC 10 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetirizine 10 mg</intervention_name>
    <description>Immediate Release Tablet</description>
    <arm_group_label>Treatment E</arm_group_label>
    <other_name>REACTINE 10 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male or female subject between the ages of 18 and 55 years, inclusive. Health&#xD;
             is defined as the absence of clinically relevant abnormalities as judged by the&#xD;
             Investigator on the basis of a detailed medical history, physical examination, blood&#xD;
             pressure, pulse rate measurements, 12-lead electrocardiogram (ECG), as well as&#xD;
             clinical laboratory tests. The responsible Investigator may request additional&#xD;
             investigations or analyses if necessary.&#xD;
&#xD;
          2. Non- or ex-tobacco user, being defined as someone who completely stopped smoking or&#xD;
             using any form of tobacco or nicotine-containing product for at least 6 months before&#xD;
             screening visit of this study.&#xD;
&#xD;
          3. For females: Postmenopausal state (i.e. at least 1 year without menses without an&#xD;
             alternative medical condition prior to the first study drug administration) or&#xD;
             premenopausal /perimenopausal state with an effective means of contraception (as&#xD;
             defined in Section 10.5.5).&#xD;
&#xD;
          4. For males: No pregnant or lactating spouse or partner at screening and willingness to&#xD;
             utilize an acceptable form of birth control with spouse or any potential partner&#xD;
             during the study.&#xD;
&#xD;
          5. Body Mass Index (BMI) ≥ 18.5 and ≤ 30 kg/m2 with a total body weight &gt;50 kg.&#xD;
&#xD;
          6. A personally signed and dated informed consent document, indicating that the subject&#xD;
             has been informed of all pertinent aspects of the study.&#xD;
&#xD;
          7. Is able to comprehend the requirements of the study (based upon clinical site&#xD;
             personnel's assessment) and is willing and able to comply with scheduled visits,&#xD;
             treatment plan, laboratory tests, and other study procedures specified within the&#xD;
             protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of prescription or non-prescription medications within 5 half-lives before the&#xD;
             first IP administration unless these are contraceptives or occasional use of other&#xD;
             medications approved by the Investigator.&#xD;
&#xD;
          2. Use of any vitamins, dietary and herbal supplements within seven days before first&#xD;
             dose of study drug.&#xD;
&#xD;
          3. History of any allergy or hypersensitivity (e.g. skin reaction, asthma, angioedema) to&#xD;
             cetirizine or any excipients of the formulations.&#xD;
&#xD;
          4. If female: is pregnant, has a positive pregnancy test at screening or prior to the&#xD;
             first study drug administration, or is planning to become pregnant during the duration&#xD;
             of the study, and/or is breast-feeding.&#xD;
&#xD;
          5. Has a history of gastrointestinal surgery other than appendectomy.&#xD;
&#xD;
          6. Has hypertension, fluid retention, or heart disease either by history or by the&#xD;
             medically qualified Investigator's medical judgment.&#xD;
&#xD;
          7. Currently suffering from asthma or has a medically significant history of asthma in&#xD;
             the opinion of the investigator.&#xD;
&#xD;
          8. Has clinically significant renal or hepatic impairment; according to the medically&#xD;
             qualified Investigator discretion.&#xD;
&#xD;
          9. Was treated with an investigational product within 28 days or within a period less&#xD;
             than 5 times the drug's half-life, whichever is longer, preceding the first dose of&#xD;
             study drug.&#xD;
&#xD;
         10. Preplanned surgical procedures during the study period as this may interfere with the&#xD;
             conduct of the study.&#xD;
&#xD;
         11. History of alcoholism or substance abuse, as judged by the Investigator, within the&#xD;
             past 6 months preceding this study.&#xD;
&#xD;
         12. Consumed alcohol beverage(s) within 48 hours preceding the first dose of study drug.&#xD;
&#xD;
         13. History of rare hereditary problems of galactose and/or lactose intolerance, lactase&#xD;
             deficiency or glucose-galactose malabsorption.&#xD;
&#xD;
         14. Any history of tuberculosis.&#xD;
&#xD;
         15. Donation or loss of blood within 28 days prior to the first treatment visit if the&#xD;
             estimated lost blood volume equaled or exceeded 50 mL.&#xD;
&#xD;
         16. Donation or loss of blood within 56 days prior to the first treatment visit if the&#xD;
             estimated lost blood volume equaled or exceeded 500 mL.&#xD;
&#xD;
         17. Has any acute or chronic medical or psychiatric condition(s) that may increase the&#xD;
             risk associated with study participation or IP administration or may interfere with&#xD;
             the interpretation of study results and, in the judgment of the medically qualified&#xD;
             Investigator, would make the subject inappropriate for entry into this study.&#xD;
&#xD;
         18. Relationship to persons involved directly in the conduct of the study (i.e., principal&#xD;
             Investigator, sub-Investigators, study coordinators, other study personnel, employees&#xD;
             or contractors of the sponsor or Johnson &amp; Johnson subsidiaries, and the family of&#xD;
             each).&#xD;
&#xD;
         19. Has any clinically important abnormal value for serum chemistry, hematology, or&#xD;
             urinalysis at screening. Laboratory values will generally be within the normal ranges,&#xD;
             although minor deviations in tests (except those explicitly specified in the inclusion&#xD;
             criteria) that are not considered clinically important by the Investigator are&#xD;
             acceptable.&#xD;
&#xD;
         20. Has a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies,&#xD;
             hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV).&#xD;
&#xD;
         21. Has a positive test for alcohol or drugs of abuse at screening or prior to the first&#xD;
             study drug administration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>No less than approximately 40% of either gender will be represented in the study population.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Sicard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Algorithme Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Algorithme (An altascience Company)</name>
      <address>
        <city>Mount-Royal</city>
        <state>Quebec</state>
        <zip>H3P 3P1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;amp;parentIdentifier=CCSURA000499&amp;amp;attachmentIdentifier=b1bd7d49-7220-4c5f-8c78-555f34b49b1d&amp;amp;fileName=CSR_CCSURA000499_Section_2_Synopsis_Redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>CSR synopsis for Bioequivalence Study.</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>November 29, 2021</last_update_submitted>
  <last_update_submitted_qc>November 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bioequivalence study</keyword>
  <keyword>Healthy volunteers</keyword>
  <keyword>Cetirizine</keyword>
  <keyword>Tablet</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cetirizine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03772158
org study id: CCSURA000499
nct id: NCT03772158
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to determine and compare the amount of study drug that gets into
      your blood after the administration of each of the three formulations of cetirizine under
      different conditions. Another objective of this study is to evaluate the effect of food on
      the amount of study drug that gets into your blood after the administration of the
      investigational formulation. Other objectives of this study are to determine the sensory
      experience and ease of swallowing the investigational formulation, as well as to determine
      the safety of test and reference formulations of cetirizine.
The purpose of this study is to establish bioequivalence of a cetirizine 10 mg chewable
      tablet manufactured at Johnson & Johnson Consumer Inc. (McNeil LLC) with two commercially
      marketed cetirizine 10 mg immediate release (IR) tablets (ZYRTEC®, US reference) and
      (Australian/EU reference), establish bioequivalence between the two commercial products
      (ZYRTEC®, US reference and REACTINE®, Australian/EU reference), and to evaluate the effect of
      food on bioavailability of the cetirizine 10 mg chewable tablet compared to the
      bioavailability of cetirizine 10 mg chewable tablet administrated with water only. In
      addition, subject's sensory experience and ease of swallowing of the test product will be
      assessed.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a randomized, single-dose, four-treatment crossover bioequivalence and food effect study of Cetirizine Chewable Tablets versus ZYRTEC® Immediate Release (IR) Tablets (US reference) and REACTINE® IR Tablets (EU and Australian marketed reference product).
The study will be conducted in two parts. Part 1 of the study will have a randomized, four way crossover study design in which 40 healthy subjects, ages 18 to 55 years, will be randomized to four sequences of Treatments A, B, D and E over consecutive periods. No less than approximately 40% of either gender will be represented in the study population. Part 2 of the study will assess a potential food effect in which all subjects will be administered Treatment C in the fifth period.
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Blinding of the test and reference products to study subjects is not feasible, because the products are different dosage forms (chewable tablets and IR tablets) and administered in different ways (with or without water and fasted or fed). Personnel conducting the bioanalyses of samples will not know the treatment sequence. The randomization code will not be available to them until the analytical tables have been finalized and audited by the Algorithme Pharma (An Altasciences Company) Quality Assurance (QA) department.
measure: The maximum observed plasma concentration (Cmax) of cetirizine
time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
description: The maximum observed plasma concentration.
measure: The area under the plasma concentration versus time curves to the last measurable concentration (AUCt)
time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
description: Area under the plasma concentration versus time curve from start of drug administration until last measurable concentration.
measure: Area under the plasma concentration versus time curve extrapolated to infinity
time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
description: Area under the plasma concentration-time curve extrapolated to infinity.
measure: The time point at which the maximum concentration of cetirizine is observed (Tmax).
time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
description: The time point at which the maximum concentration of cetirizine occurs.
measure: The terminal elimination half-life (T1/2) of cetirizine in plasma
time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
description: The time it takes for the cetirizine plasma concentration to fall to half of its original value.
measure: The terminal elimination rate constant (lambda z) for cetirizine in plasma.
time frame: At baseline, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 28 and 32 hours after the start of dose administration.
description: The rate at which the drug is removed from the body system.
measure: To assess subject's sensory experience and ease of swallowing of the test product
time frame: Assessed one minute after dosing, and preferably completed within 15 minutes of dosing for treatments A, B and C
description: A questionaire with 5 product sensory questions for study subjects to answer.
measure: Number of patients with adverse events.
time frame: Approximately 3 months. From signed informed consent until 30 days after last treatment administration.
description: An adverse event is any untoward medical occurrence in a subject after they have signed an informed consent for a trial involving an investigational product.
measure: The extrapolated part of the area under the plasma concentration versus time curve of cetirizine
time frame: Extrapolated from 12 hours after start of drug administration until 48 hours
description: The area under the plasma concentration versus time curve from 12 hours after start of drug administration until 48 hours after start of drug administration.
arm group label: Treatment A
arm group type: Experimental
description: Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast and followed with 240 mL ambient water. Subjects will be instructed to chew the tablet completely before swallowing.
arm group label: Treatment B
arm group type: Experimental
description: Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast without water. Subjects will be instructed to chew the tablet completely before swallowing.
arm group label: Treatment C
arm group type: Experimental
description: Single dose of 10 mg cetirizine as a chewable tablet, administered orally after a 10-hour overnight fast and 30 minutes after the start of the standard high-fat breakfast and followed with 240 mL ambient water. Subjects will be instructed to chew the tablet completely before swallowing.
arm group label: Treatment D
arm group type: Active Comparator
description: Single dose of currently marketed US 10 mg cetirizine as immediate release tablet (ZYRTEC®), administered orally after a 10-hour overnight fast and followed with 240 mL ambient water.
arm group label: Treatment E
arm group type: Active Comparator
description: Single dose of currently marketed EU/Australian 10 mg cetirizine film coated tablet (REACTINE®) administered orally after a 10-hour overnight fast and followed with 240 mL ambient water.
intervention type: Drug
intervention name: Cetirizine 10mg
description: Chewable tablet
arm group label: Treatment A
arm group label: Treatment B
arm group label: Treatment C
other name: Test product
intervention type: Drug
intervention name: Cetirizine 10 mg
description: Immediate Release Tablet
arm group label: Treatment D
other name: ZYRTEC 10 mg
intervention type: Drug
intervention name: Cetirizine 10 mg
description: Immediate Release Tablet
arm group label: Treatment E
other name: REACTINE 10 mg
criteria: 
gender: All
gender based: Yes
gender description: No less than approximately 40% of either gender will be represented in the study population.
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Sicard, MD
role: Principal Investigator
affiliation: Algorithme Pharma Inc
facility: 
country: Canada
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;parentIdentifier=CCSURA000499&amp;attachmentIdentifier=b1bd7d49-7220-4c5f-8c78-555f34b49b1d&amp;fileName=CSR_CCSURA000499_Section_2_Synopsis_Redacted.pdf&amp;versionIdentifier=
description: CSR synopsis for Bioequivalence Study.
responsible party type: Sponsor
mesh term: Cetirizine
sharing ipd: Undecided