<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/NCT02196662</url>
  </required_header>
  <id_info>
    <org_study_id>110200</org_study_id>
    <nct_id>NCT02196662</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers</brief_title>
  <acronym>IBD98-M</acronym>
  <official_title>Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Holy Stone Healthcare Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Holy Stone Healthcare Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to compare the rate and extent of absorption of&#xD;
      mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus&#xD;
      Delzicol 400 mg delayed-release capsule (mesalamine Reference), administered as a single oral&#xD;
      dose of 2 x 200 mg-28.75 mg delayed-release capsule (total dose of 400 mg-57.50 mg) or 1 x&#xD;
      400 mg delayed-release capsule under fasting conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Safety population The safety population is defined as all subjects who received at least one&#xD;
      dose of the study medication.&#xD;
&#xD;
      Pharmacokinetic Population The pharmacokinetic population will include all subjects&#xD;
      completing at least 2 periods and for whom the pharmacokinetic profile can be adequately&#xD;
      characterised.&#xD;
&#xD;
      Any subject with pre-dose concentrations for mesalamine will be excluded from the&#xD;
      pharmacokinetic population for this analyte if the pre-dose concentration is greater than 5%&#xD;
      of the Cmax value of that period for this subject.&#xD;
&#xD;
      Data from subjects who experienced emesis during the sampling interval and who were not&#xD;
      withdrawn as per criterion established under section 9.10 may be evaluated after completion&#xD;
      of the pharmacokinetic analysis. Any subject who experienced emesis within 2 times median&#xD;
      Tmax of the current study (based on the Reference product) will be excluded from the&#xD;
      statistical analysis. Data (concentrations and pharmacokinetic parameters) from subjects&#xD;
      excluded due to a pre dose concentration greater than 5% of their Cmax or from subjects&#xD;
      withdrawn due to adverse events or vomiting episodes will be presented but excluded from&#xD;
      descriptive statistics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the curve in plasma of IBD98-M</measure>
    <time_frame>Day 5</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IBD98-M: mesalamine-sodium hyaluronate 200mg-28.75mg X2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IBD98-M without HA: Mesalamine 200mg X2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Delzicol 200 mg X2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IBD98-M:</intervention_name>
    <description>single adiministration</description>
    <arm_group_label>Treatment A</arm_group_label>
    <other_name>Mesalamine-Sodium Hyaluronic 400 mg-57.5 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IBD98-M without HA</intervention_name>
    <description>single adiministration</description>
    <arm_group_label>Treatment B</arm_group_label>
    <other_name>IBD98-M without HA: Mesalamine 400 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Delzicol</intervention_name>
    <description>single adiministration</description>
    <arm_group_label>Treatment C</arm_group_label>
    <other_name>Mesalamine 400 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, smoker (no more than 25 cigarettes daily) or non-smoker, 18 years of&#xD;
             age and older, with BMI &gt; 18.5 and &lt; 30.0 kg/m2 and body weight ≥ 50.0 kg for males&#xD;
             and ≥ 45.0 kg for females.&#xD;
&#xD;
          2. Healthy as defined by:&#xD;
&#xD;
               -  the absence of clinically significant illness and surgery within 4 weeks prior to&#xD;
                  dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated&#xD;
                  for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the&#xD;
                  Qualified Investigator.&#xD;
&#xD;
               -  the absence of clinically significant history of neurological, endocrinal,&#xD;
                  cardiovascular, pulmonary, hematological, immunologic, psychiatric,&#xD;
                  gastrointestinal, renal, hepatic, and metabolic disease.&#xD;
&#xD;
               -  the absence of history or known pyloric stenosis.&#xD;
&#xD;
               -  the absence of known gastric or duodenal ulcer.&#xD;
&#xD;
               -  the absence of urinary tract obstruction.&#xD;
&#xD;
          3. Females of childbearing potential who are sexually active with a male partner must be&#xD;
             willing to use one of the following acceptable contraceptive method throughout the&#xD;
             study and for 30 days after the last study drug administration:&#xD;
&#xD;
               -  intra-uterine contraceptive device placed at least 4 weeks prior to study drug&#xD;
                  administration&#xD;
&#xD;
               -  condom with intravaginally applied spermicide starting at least 14 days prior to&#xD;
                  study drug administration&#xD;
&#xD;
               -  hormonal contraceptives starting at least 4 weeks prior to study drug&#xD;
                  administration and must agree to use the same hormonal contraceptive throughout&#xD;
                  the study&#xD;
&#xD;
               -  sterile male partner (vasectomized since at least 6 months).&#xD;
&#xD;
          4. Capable of consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any clinically significant abnormality or abnormal laboratory test results found&#xD;
             during medical screening or positive test for hepatitis B, hepatitis C, or HIV found&#xD;
             during medical screening.&#xD;
&#xD;
          2. Positive urine drug screen at screening.&#xD;
&#xD;
          3. History of allergic reactions to mesalamine, salicylates, aminosalicylates, hyaluronic&#xD;
             acid, or other related drugs.&#xD;
&#xD;
          4. Positive pregnancy test at screening.&#xD;
&#xD;
          5. Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the&#xD;
             subject from participating in the study.&#xD;
&#xD;
          6. Clinically significant electrocardiogram (ECG) abnormalities or vital sign&#xD;
             abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood&#xD;
             pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at&#xD;
             screening.&#xD;
&#xD;
          7. History of significant alcohol abuse within one year prior to screening or regular use&#xD;
             of alcohol within six months prior to the screening visit (more than fourteen units of&#xD;
             alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).&#xD;
&#xD;
          8. History of significant drug abuse within one year prior to screening or use of soft&#xD;
             drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs&#xD;
             (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening.&#xD;
&#xD;
          9. Participation in a clinical trial involving the administration of an investigational&#xD;
             or marketed drug within 30 days (90 days for biologics) prior to the first dosing or&#xD;
             concomitant participation in an investigational study involving no drug&#xD;
             administration.&#xD;
&#xD;
         10. Use of medication other than topical products without significant systemic absorption&#xD;
             and hormonal contraceptives:&#xD;
&#xD;
               -  prescription medication within 14 days prior to the first dosing;&#xD;
&#xD;
               -  over-the-counter products including natural health products (e.g. food&#xD;
                  supplements and herbal supplements) within 7 days prior to the first dosing, with&#xD;
                  the exception of the occasional use of acetaminophen (up to 2 g daily);&#xD;
&#xD;
               -  a depot injection or an implant of any drug (other than hormonal contraceptives)&#xD;
                  within 3 months prior to the first dosing.&#xD;
&#xD;
         11. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding&#xD;
             volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than&#xD;
             499 mL within 56 days prior to the first dosing.&#xD;
&#xD;
         12. Hemoglobin &lt;128 g/L (males) and &lt;115 g/L (females) and hematocrit &lt;0.37 L/L (males)&#xD;
             and &lt;0.32 L/L (females) at screening.&#xD;
&#xD;
         13. Breast-feeding subject.&#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>Denis Audet, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>inVentiv</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>inVentiv Health Clinique</name>
      <address>
        <city>Quebec</city>
        <zip>G1P0A2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>July 15, 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>April 20, 2015</last_update_submitted>
  <last_update_submitted_qc>April 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 22, 2015</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>Mesalamine</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/NCT02196662
org study id: 110200
nct id: NCT02196662
lead sponsor: 
has dmc: Yes
The primary objective of this study is to compare the rate and extent of absorption of
      mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus
      Delzicol 400 mg delayed-release capsule (mesalamine Reference), administered as a single oral
      dose of 2 x 200 mg-28.75 mg delayed-release capsule (total dose of 400 mg-57.50 mg) or 1 x
      400 mg delayed-release capsule under fasting conditions.
Safety population The safety population is defined as all subjects who received at least one
      dose of the study medication.

      Pharmacokinetic Population The pharmacokinetic population will include all subjects
      completing at least 2 periods and for whom the pharmacokinetic profile can be adequately
      characterised.

      Any subject with pre-dose concentrations for mesalamine will be excluded from the
      pharmacokinetic population for this analyte if the pre-dose concentration is greater than 5%
      of the Cmax value of that period for this subject.

      Data from subjects who experienced emesis during the sampling interval and who were not
      withdrawn as per criterion established under section 9.10 may be evaluated after completion
      of the pharmacokinetic analysis. Any subject who experienced emesis within 2 times median
      Tmax of the current study (based on the Reference product) will be excluded from the
      statistical analysis. Data (concentrations and pharmacokinetic parameters) from subjects
      excluded due to a pre dose concentration greater than 5% of their Cmax or from subjects
      withdrawn due to adverse events or vomiting episodes will be presented but excluded from
      descriptive statistics.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Area under the curve in plasma of IBD98-M
time frame: Day 5
arm group label: Treatment A
arm group type: Experimental
description: IBD98-M: mesalamine-sodium hyaluronate 200mg-28.75mg X2
arm group label: Treatment B
arm group type: Experimental
description: IBD98-M without HA: Mesalamine 200mg X2
arm group label: Treatment C
arm group type: Experimental
description: Delzicol 200 mg X2
intervention type: Drug
intervention name: IBD98-M:
description: single adiministration
arm group label: Treatment A
other name: Mesalamine-Sodium Hyaluronic 400 mg-57.5 mg
intervention type: Drug
intervention name: IBD98-M without HA
description: single adiministration
arm group label: Treatment B
other name: IBD98-M without HA: Mesalamine 400 mg
intervention type: Drug
intervention name: Delzicol
description: single adiministration
arm group label: Treatment C
other name: Mesalamine 400 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Denis Audet, M.D.
role: Principal Investigator
affiliation: inVentiv
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Mesalamine