<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/NCT01666678</url>
  </required_header>
  <id_info>
    <org_study_id>16135</org_study_id>
    <nct_id>NCT01666678</nct_id>
  </id_info>
  <brief_title>Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination</brief_title>
  <acronym>Morpheus PK</acronym>
  <official_title>A Bioavailability Study of Naproxen Sodium and Diphenhydramine Hydrochloride Under Fasting Conditions and Naproxen Sodium and Diphenhydramine Hydrochloride Combination Under Fasting and Fed Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the current trial is to evaluate the bioavailability of a single oral dose of&#xD;
      naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently&#xD;
      marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or&#xD;
      DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</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>AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of naproxen sodium</measure>
    <time_frame>within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of DPH HCL(Diphenhydramine Hydrochloride)</measure>
    <time_frame>within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax(Maximum drug concentration) in plasma of naproxen sodium</measure>
    <time_frame>within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax(Maximum drug concentration) in plasma of DPH HCL(Diphenhydramine Hydrochloride)</measure>
    <time_frame>within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events as a measure of safety and tolerability</measure>
    <time_frame>up to 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Therapeutic Equivalence</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY98-7111</intervention_name>
    <description>2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naproxen Sodium (Aleve, BAYH6689)</intervention_name>
    <description>2 x Naproxen Sodium 220 mg under fasting conditions</description>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diphenhydramine HCl</intervention_name>
    <description>2 x Diphenhydramine HCl 25 mg under fasting conditions</description>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY98-7111</intervention_name>
    <description>2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fed conditions</description>
    <arm_group_label>Arm 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health, ambulatory male and female subjects between 18 to 55 years of age inclusive&#xD;
&#xD;
          -  Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight &gt;50 kg&#xD;
             (110 lbs)&#xD;
&#xD;
          -  Results of screening and clinical laboratory tests are within normal range or&#xD;
             considered not clinically significant by the Principal Investigator or Sponsor&#xD;
&#xD;
          -  Female subjects of childbearing potential must be using a medically acceptable form of&#xD;
             birth control for at least 1 month prior to screening (3 months on oral&#xD;
             contraceptives), e.g., oral or patch contraceptives, intrauterine device,&#xD;
             Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and&#xD;
             Day 0 for each Dosing Period. Female subjects of non childbearing potential must be&#xD;
             amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity to aspirin (ASA), naproxen sodium, NSAIDs, acetaminophen,&#xD;
             DPH HCL, and similar pharmacological agents or components of the products&#xD;
&#xD;
          -  History of hypersensitivity to any of the food products in the standardized breakfast&#xD;
             or cannot consume all food/beverage items contained in the standardized breakfast&#xD;
&#xD;
          -  Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (OTC or&#xD;
             prescription) 7 days prior to dosing or during the Dosing Periods, other than trial&#xD;
             treatment&#xD;
&#xD;
          -  Use of any over-the-counter or prescription medications (except acceptable forms of&#xD;
             birth control) within 10 days prior to dosing or throughout the trial, unless in the&#xD;
             opinion of the Investigator, the medication will not interfere with the trial&#xD;
             procedures, data integrity, or compromise the safety of the subject&#xD;
&#xD;
          -  Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or&#xD;
             piercings during the trial or 1-2 weeks after treatment&#xD;
&#xD;
          -  Loss of blood in excess of 500 ml within 56 days of the first dose of trial treatment&#xD;
             (e.g., donation, plasmapheresis or injury)&#xD;
&#xD;
          -  History of gastrointestinal bleeding or perforation, related to previous NSAID therapy&#xD;
             or active or history of recurrent peptic ulcer/hemorrhage (two or more distinct&#xD;
             episodes of proven ulceration or bleeding)&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases&#xD;
             or malignancies&#xD;
&#xD;
          -  Smokers or currently consuming any type of tobacco product(s) including any smoking&#xD;
             cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)&#xD;
&#xD;
          -  Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to&#xD;
             refrain from use during the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bioequivalence</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diphenhydramine</mesh_term>
    <mesh_term>Promethazine</mesh_term>
    <mesh_term>Naproxen</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/NCT01666678
org study id: 16135
nct id: NCT01666678
lead sponsor: 
has dmc: No
The purpose of the current trial is to evaluate the bioavailability of a single oral dose of
      naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently
      marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or
      DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of naproxen sodium
time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
measure: AUC(0-tn) (area under the measurement versus time curve from time 0 to the last data point) of DPH HCL(Diphenhydramine Hydrochloride)
time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
measure: Cmax(Maximum drug concentration) in plasma of naproxen sodium
time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
measure: Cmax(Maximum drug concentration) in plasma of DPH HCL(Diphenhydramine Hydrochloride)
time frame: within 30 minutes prior to dosing (baseline) and 10, 20, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 hours post dosing
measure: Number of participants with adverse events as a measure of safety and tolerability
time frame: up to 6 weeks
arm group label: Arm 1
arm group type: Experimental
arm group label: Arm 2
arm group type: Active Comparator
arm group label: Arm 3
arm group type: Active Comparator
arm group label: Arm 4
arm group type: Experimental
intervention type: Drug
intervention name: BAY98-7111
description: 2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions
arm group label: Arm 1
intervention type: Drug
intervention name: Naproxen Sodium (Aleve, BAYH6689)
description: 2 x Naproxen Sodium 220 mg under fasting conditions
arm group label: Arm 2
intervention type: Drug
intervention name: Diphenhydramine HCl
description: 2 x Diphenhydramine HCl 25 mg under fasting conditions
arm group label: Arm 3
intervention type: Drug
intervention name: BAY98-7111
description: 2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fed conditions
arm group label: Arm 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diphenhydramine
mesh term: Promethazine
mesh term: Naproxen