<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/NCT02195804</url>
  </required_header>
  <id_info>
    <org_study_id>1144.3</org_study_id>
    <nct_id>NCT02195804</nct_id>
  </id_info>
  <brief_title>Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) in Fasting, Healthy Male Volunteers</brief_title>
  <official_title>A Phase I Open-label, Randomised, Single Dose, Three-way Crossover Relative Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) Formulations Following Oral Administration in Fasting, Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of this study is to establish the relative bioavailability (BA) of two&#xD;
      different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over&#xD;
      the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation&#xD;
      following oral single dose administration in fasting healthy male volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2009</start_date>
  <primary_completion_date type="Actual">June 2009</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>Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of ranitidine in plasma (Cmax)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from dosing to the maximum concentration of ranitidine in plasma (tmax)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant in plasma (λz)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life of ranitidine in plasma (t1/2)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time of the analyte in the body after po administration (MRTpo)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)</measure>
    <time_frame>up to 16 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 38 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>24 hours after drug dosing at the end of each treatment period</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Ranitidine HCL ODT Vanilla-Mint</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ranitidine HCL ODT RM Vanilla-Mint</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ranitidine HCL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Maximum Strength ZANTAC 150®</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranitidine hydrochloride ODT</intervention_name>
    <description>Ranitidine hydrochloride ODT#1 150 mg (Vanilla-Mint)</description>
    <arm_group_label>Ranitidine HCL ODT Vanilla-Mint</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranitidine hydrochloride ODT RM</intervention_name>
    <description>Ranitidine hydrochloride ODT Reduced Mannitol (RM) 150 mg Vanilla-Mint (ODT#2)</description>
    <arm_group_label>Ranitidine HCL ODT RM Vanilla-Mint</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranitidine hydrochloride</intervention_name>
    <arm_group_label>Ranitidine HCL</arm_group_label>
    <other_name>Maximum Strength ZANTAC 150®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects based on: complete medical history, including a physical&#xD;
             examination, vital signs (pulse rate (PR), systolic &amp; diastolic blood pressure (BP)&#xD;
             and body temperature), 12-lead electrocardiogram (ECG) and clinical laboratory tests&#xD;
&#xD;
          -  Age ≥ 18 and Age ≤ 60 years&#xD;
&#xD;
          -  BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index) and body weight of ≥ 55 kg&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good Clinical Practice and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinically relevant abnormality found on the screening physical examination&#xD;
             (including BP, PR) or ECG or in the opinion of the investigator the patient is not&#xD;
             suitable for the study&#xD;
&#xD;
          -  Any evidence of an acute or chronic gastrointestinal conditions or relevant&#xD;
             concomitant medical disease&#xD;
&#xD;
          -  History of acute porphyria&#xD;
&#xD;
          -  History of peptic ulcer disease&#xD;
&#xD;
          -  Heartburn requiring treatment (OTC or prescription medicine) within the last 30 days&#xD;
&#xD;
          -  History of surgery of the gastrointestinal tract surgery (except appendectomy and&#xD;
             cholecystectomy)&#xD;
&#xD;
          -  History of relevant allergy / hypersensitivity (including allergy to H2 inhibitor) to&#xD;
             the drug class, ranitidine hydrochloride or its excipients)&#xD;
&#xD;
          -  Intake of prescription or over-the-counter (OTC) drugs with a long half-life (&gt;24&#xD;
             hours) within at least 2 weeks or less than 10 half-lives of the respective drug prior&#xD;
             to administration or during the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within 30 days prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Inability to refrain from alcohol use 48 hours prior to drug administration until the&#xD;
             end of the study visit for each treatment period&#xD;
&#xD;
          -  History of alcohol (more than 60 g/day) or drug abuse&#xD;
&#xD;
          -  Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance as&#xD;
             determined by the investigator&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  Subjects who test positive upon drug screening&#xD;
&#xD;
          -  Subjects who consume caffeine or xanthine-containing drinks or foods (coffee, tea,&#xD;
             cola, energy drinks, chocolate, etc.) 48 hours prior to study drug administration&#xD;
&#xD;
          -  Subjects who consume citrus fruits and juices, (in particular grapefruits and Seville&#xD;
             oranges, sour or bitter oranges), or products containing St. John's wort (Hypericum&#xD;
             perforatum) are not allowed 7 days prior to dose administration&#xD;
&#xD;
          -  Excessive physical activity or exercise (such as organized sports) during the trial&#xD;
             period&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</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>Ranitidine</mesh_term>
    <mesh_term>Ranitidine bismuth citrate</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/NCT02195804
org study id: 1144.3
nct id: NCT02195804
lead sponsor: 
The objective of this study is to establish the relative bioavailability (BA) of two
      different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over
      the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation
      following oral single dose administration in fasting healthy male volunteers
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
time frame: up to 16 hours after drug administration
measure: Maximum measured concentration of ranitidine in plasma (Cmax)
time frame: up to 16 hours after drug administration
measure: Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
time frame: up to 16 hours after drug administration
measure: Time from dosing to the maximum concentration of ranitidine in plasma (tmax)
time frame: up to 16 hours after drug administration
measure: Terminal rate constant in plasma (λz)
time frame: up to 16 hours after drug administration
measure: Terminal half-life of ranitidine in plasma (t1/2)
time frame: up to 16 hours after drug administration
measure: Mean residence time of the analyte in the body after po administration (MRTpo)
time frame: up to 16 hours after drug administration
measure: Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
time frame: up to 16 hours after drug administration
measure: Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
time frame: up to 16 hours after drug administration
measure: Number of patients with adverse events
time frame: up to 38 days
measure: Global assessment of tolerability by investigator on a 4-point scale
time frame: 24 hours after drug dosing at the end of each treatment period
arm group label: Ranitidine HCL ODT Vanilla-Mint
arm group type: Experimental
arm group label: Ranitidine HCL ODT RM Vanilla-Mint
arm group type: Experimental
arm group label: Ranitidine HCL
arm group type: Active Comparator
description: Maximum Strength ZANTAC 150®
intervention type: Drug
intervention name: Ranitidine hydrochloride ODT
description: Ranitidine hydrochloride ODT#1 150 mg (Vanilla-Mint)
arm group label: Ranitidine HCL ODT Vanilla-Mint
intervention type: Drug
intervention name: Ranitidine hydrochloride ODT RM
description: Ranitidine hydrochloride ODT Reduced Mannitol (RM) 150 mg Vanilla-Mint (ODT#2)
arm group label: Ranitidine HCL ODT RM Vanilla-Mint
intervention type: Drug
intervention name: Ranitidine hydrochloride
arm group label: Ranitidine HCL
other name: Maximum Strength ZANTAC 150®
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Ranitidine
mesh term: Ranitidine bismuth citrate