<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/NCT03271983</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00071790</org_study_id>
    <nct_id>NCT03271983</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Metronidazole Dermal Products</brief_title>
  <official_title>Evaluation of the Bioavailability of Metronidazole Dermal Products</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Food and Drug Administration (FDA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Generate human PK data by collecting data following the application of metronidazole&#xD;
      formulations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study is intended to develop models for in vitro/in vivo correlation (IVIVC) of&#xD;
      drug absorption from dermal products. This study will use metronidazole products that have&#xD;
      already been approved by the Food and Drug Administration (FDA) and are already sold to&#xD;
      customers in the United States; will not include any placebos.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2019</start_date>
  <completion_date type="Actual">November 3, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PK Parameters</measure>
    <time_frame>3 study sessions/subject; each session was 25 h; blood samples obtained at the following time points: -60 min, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 23, 24, 25 h; at least one week washout period between each study session</time_frame>
    <description>Area under the concentration-time curve from 0 to 25 h</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Bioequivalence</condition>
  <arm_group>
    <arm_group_label>metronidazole gel 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>RLD gel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>metronidazole gel 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>generic gel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>metronidazole cream</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>generic cream</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole gel 1</intervention_name>
    <description>RLD gel</description>
    <arm_group_label>metronidazole gel 1</arm_group_label>
    <other_name>metronidazole</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole gel 2</intervention_name>
    <description>generic gel</description>
    <arm_group_label>metronidazole gel 2</arm_group_label>
    <other_name>metronidazole</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole cream</intervention_name>
    <description>generic cream</description>
    <arm_group_label>metronidazole cream</arm_group_label>
    <other_name>metronidazole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men or non-pregnant, women who are of any ethnic background between the age of 18 to&#xD;
             45 years old&#xD;
&#xD;
          2. Subjects must be non-smokers/tobacco users (must have refrained from the use of&#xD;
             nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars,&#xD;
             chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2&#xD;
             months and are not currently using tobacco products&#xD;
&#xD;
          3. Provide written informed consent before initiation of any of the study procedures&#xD;
&#xD;
          4. Agree not to participate in another clinical trial/study during the study period or to&#xD;
             participate in an investigational drug study for at least 1 month after the last study&#xD;
             session&#xD;
&#xD;
          5. Able to adhere to the study protocol and study restrictions&#xD;
&#xD;
          6. Able to participate in all study sessions&#xD;
&#xD;
          7. Subjects have upper arms large enough to allow for placement of 200 cm2 [31 in2] area&#xD;
             for applications of gel or cream. The arm distance from the greater tubercle to the&#xD;
             olecranon process should be a minimum of 30 cm. The circumference of the upper arms&#xD;
             should be a minimum of 30 cm.&#xD;
&#xD;
          8. Subjects deemed to be healthy as judged by the Medically Accountable Investigator&#xD;
             (MAI) and determined by medical history, physical examination and medication history&#xD;
&#xD;
          9. Negative urine drug screening test (cannabinoids, amphetamines, barbiturates,&#xD;
             benzodiazepine, cocaine, methadone, opiates, PCP)&#xD;
&#xD;
         10. Have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb),&#xD;
             platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN),&#xD;
             creatinine, alanine transaminase (ALT) and aspartate aminotransferase (AST)&#xD;
&#xD;
         11. Have normal screening laboratories for urine protein and urine glucose&#xD;
&#xD;
         12. Female subjects must be of non-childbearing potential (as defined as surgically&#xD;
             sterile [i.e. history of hysterectomy or tubal ligation] or postmenopausal for more&#xD;
             than 1 year), or if of childbearing potential must be non-pregnant at the time of&#xD;
             enrollment and on the morning of each study session, and must agree to use reliable&#xD;
             hormonal or barrier birth control such as implants, injectables, combined oral&#xD;
             contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized&#xD;
             partner&#xD;
&#xD;
         13. Agrees not to donate blood to a blood bank throughout participation in the study and&#xD;
             for at least 3 months after last study session&#xD;
&#xD;
         14. Have a normal ECG; must not have the following to be acceptable: pathologic Q wave&#xD;
             abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right&#xD;
             bundle branch block, left bundle branch block. (sinus rhythm is between 55-100 beats&#xD;
             per minute)&#xD;
&#xD;
         15. Have normal vital signs:&#xD;
&#xD;
               -  Temperature 35-37.9°C (95-100.3°F)&#xD;
&#xD;
               -  Systolic blood pressure 90-165 mmHg&#xD;
&#xD;
               -  Diastolic blood pressure 60-100 mmHg&#xD;
&#xD;
               -  Heart rate 55-100 beats per minute&#xD;
&#xD;
               -  Respiration rate 12-20 breaths per minute&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy&#xD;
             test at enrollment or positive urine pregnancy test on the morning of the first day of&#xD;
             any study session&#xD;
&#xD;
          2. Smokers/tobacco users (current use or use over the previous 2 months of&#xD;
             nicotine-containing substances (e.g., cigarettes, cigars, chewing tobacco, gum, snuff,&#xD;
             patch or electronic cigarettes)&#xD;
&#xD;
          3. Current participation in any ongoing investigational drug trial/study or clinical drug&#xD;
             trial/study&#xD;
&#xD;
          4. History as either reported by the subject or evident to the investigator of infectious&#xD;
             disease or skin infection or of chronic skin disease (e.g., psoriasis, atopic&#xD;
             dermatitis)&#xD;
&#xD;
          5. History of diabetes&#xD;
&#xD;
          6. History of significant skin cancers (e.g., melanoma, squamous cell carcinoma) except&#xD;
             basal cell carcinomas that were superficial and did not involve the investigative&#xD;
             sites&#xD;
&#xD;
          7. Body Mass Index (BMI) ≥30 kg/m2&#xD;
&#xD;
          8. History of chronic obstructive pulmonary disease or cor pulmonale, or substantially&#xD;
             decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory&#xD;
             depression&#xD;
&#xD;
          9. Active positive Hepatitis B, C and/or HIV test results&#xD;
&#xD;
         10. Positive urine drug screening test&#xD;
&#xD;
         11. Use of chronic prescription medications during the period 0 to 30 days; or&#xD;
             over-the-counter medications (e.g. antihistamines, topical corticosteroids) and short&#xD;
             term (&lt;30 days) prescription medications during the period 0-3 days before a study&#xD;
             session (vitamins, herbal supplements and birth control medications not included)&#xD;
&#xD;
         12. Currently taking daily anticoagulants (warfarin, heparin, rivaroxaban, dabigatran,&#xD;
             etc…) within the past month prior to entry into the study&#xD;
&#xD;
         13. History of blood dyscrasia (abnormal in structure, function and quality)&#xD;
&#xD;
         14. History of Crohn's disease&#xD;
&#xD;
         15. Donation or loss of greater than one pint of blood within 60 days of entry to the&#xD;
             study&#xD;
&#xD;
         16. Any prior adverse reaction or hypersensitivity to metronidazole, parabens, other&#xD;
             inactive ingredients in the topical gel or cream formulations&#xD;
&#xD;
         17. Received an experimental agent (vaccine, drug, biologic, device, blood product or&#xD;
             medication) within 1 month before enrollment in this study or expects to receive an&#xD;
             experimental agent during the study&#xD;
&#xD;
         18. Consumption (food or drink) of alcohol within 48 h prior to dose administration&#xD;
&#xD;
         19. Any condition that would, in the opinion of the Medically Accountable Investigator&#xD;
             (MAI), place the subject at an unacceptable risk of injury or render the subject&#xD;
             unable to meet the requirements of the protocol&#xD;
&#xD;
         20. Subject has an obvious difference in skin color between arms or the presence of a skin&#xD;
             condition, excessive hair at the application site (upper arms), sunburn, raised moles&#xD;
             or scars, open sores at application site (upper arms), scar tissue, tattoo, or&#xD;
             coloration that would interfere with placement of metronidazole products, skin&#xD;
             assessment, or reactions to metronidazole&#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>Audra L Stinchcomb, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, Baltimore School of Pharmacy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Clinical Research Center (GCRC) at the University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <results_first_submitted>December 13, 2021</results_first_submitted>
  <results_first_submitted_qc>March 3, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 17, 2022</results_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Audra Stinchcomb</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03271983/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Topical Metronidazole</title>
          <description>Study session 1: metronidazole gel (RLD); followed by at least a one week washout period.&#xD;
Study session 2: metronidazole gel (generic); followed by at least a one week washout period.&#xD;
Study session 3: metronidazole cream (generic)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7">The plan was to do n=12 volunteers; however, funding was terminated due to pandemic so only 7 volunteers were completed.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Topical Metronidazole</title>
          <description>Study session 1: metronidazole gel (RLD); followed by at least a one week washout period.&#xD;
Study session 2: metronidazole gel (generic); followed by at least a one week washout period.&#xD;
Study session 3: metronidazole cream (generic)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.5" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>PK Parameters</title>
        <description>Area under the concentration-time curve from 0 to 25 h</description>
        <time_frame>3 study sessions/subject; each session was 25 h; blood samples obtained at the following time points: -60 min, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 23, 24, 25 h; at least one week washout period between each study session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Session 1 (RLD Gel)</title>
            <description>Metronidazole gel: RLD gel</description>
          </group>
          <group group_id="O2">
            <title>Study Session 2 (Generic Gel)</title>
            <description>Metronidazole gel: generic gel</description>
          </group>
          <group group_id="O3">
            <title>Study Session 3 (Generic Cream)</title>
            <description>Metronidazole cream: generic cream</description>
          </group>
        </group_list>
        <measure>
          <title>PK Parameters</title>
          <description>Area under the concentration-time curve from 0 to 25 h</description>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="283" lower_limit="118" upper_limit="677"/>
                    <measurement group_id="O2" value="341" lower_limit="226" upper_limit="515"/>
                    <measurement group_id="O3" value="189" lower_limit="81.3" upper_limit="441"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Study Session 1 (RLD Gel)</title>
          <description>Metronidazole gel: RLD gel</description>
        </group>
        <group group_id="E2">
          <title>Study Session 2 (Generic Gel)</title>
          <description>Metronidazole gel: generic gel</description>
        </group>
        <group group_id="E3">
          <title>Study Session 3 (Generic Cream)</title>
          <description>Metronidazole cream: generic cream</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased blood pressure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Decreased heart rate</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>ERYTHEMA (skin reddening)</sub_title>
                <description>from tape used to hold IV in place</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain at IV site</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Audra Stinchcomb</name_or_title>
      <organization>University of Maryland, Baltimore</organization>
      <phone>410-706-2646</phone>
      <email>astinchc@rx.umaryland.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03271983
org study id: HP-00071790
nct id: NCT03271983
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Generate human PK data by collecting data following the application of metronidazole
      formulations.
This research study is intended to develop models for in vitro/in vivo correlation (IVIVC) of
      drug absorption from dermal products. This study will use metronidazole products that have
      already been approved by the Food and Drug Administration (FDA) and are already sold to
      customers in the United States; will not include any placebos.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: PK Parameters
time frame: 3 study sessions/subject; each session was 25 h; blood samples obtained at the following time points: -60 min, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 23, 24, 25 h; at least one week washout period between each study session
description: Area under the concentration-time curve from 0 to 25 h
arm group label: metronidazole gel 1
arm group type: Other
description: RLD gel
arm group label: metronidazole gel 2
arm group type: Other
description: generic gel
arm group label: metronidazole cream
arm group type: Other
description: generic cream
intervention type: Drug
intervention name: Metronidazole gel 1
description: RLD gel
arm group label: metronidazole gel 1
other name: metronidazole
intervention type: Drug
intervention name: Metronidazole gel 2
description: generic gel
arm group label: metronidazole gel 2
other name: metronidazole
intervention type: Drug
intervention name: Metronidazole cream
description: generic cream
arm group label: metronidazole cream
other name: metronidazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Audra L Stinchcomb, PhD
role: Principal Investigator
affiliation: University of Maryland, Baltimore School of Pharmacy
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Audra Stinchcomb
investigator title: Professor
mesh term: Metronidazole
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 