<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/NCT03282929</url>
  </required_header>
  <id_info>
    <org_study_id>N-A-PH1-15-050</org_study_id>
    <nct_id>NCT03282929</nct_id>
  </id_info>
  <brief_title>Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)</brief_title>
  <official_title>An Single-dose, Open Label, Randomized Cross-over Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch &amp; Lomb Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bausch &amp; Lomb Incorporated</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single dose, open label, randomized cross-over study to explore the pharmacokinetics and&#xD;
      pharmacodynamics of epinephrine in healthy male and female subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single dose, open label, randomized cross-over study to explore the pharmacokinetics and&#xD;
      pharmacodynamics of epinephrine in healthy male and female subjects with different&#xD;
      skin-to-muscle depth (STMD) of the thigh after injections with four different marketed&#xD;
      auto-injectors&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2017</start_date>
  <completion_date type="Actual">October 15, 2018</completion_date>
  <primary_completion_date type="Actual">September 28, 2018</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>Pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin-to-muscle depth (STMD) of the thigh after injections with four different marketed auto-injectors</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>14 days</time_frame>
    <description>Maximum observed drug concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tmax</measure>
    <time_frame>14 days</time_frame>
    <description>Time of the maximum drug concentration (obtained without interpolation). If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Anaphylaxis</condition>
  <arm_group>
    <arm_group_label>Part 1 Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Part 1</intervention_name>
    <description>A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order</description>
    <arm_group_label>Part 1 Group 1</arm_group_label>
    <other_name>Group 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Part 2 Group 1</intervention_name>
    <description>300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)</description>
    <arm_group_label>Part 2 group 1</arm_group_label>
    <other_name>Group 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Part 2 group 2</intervention_name>
    <description>500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)</description>
    <arm_group_label>Part 2 Group 2</arm_group_label>
    <other_name>Group 2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Part 2 group 3</intervention_name>
    <description>300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)</description>
    <arm_group_label>Part 2 Group 3</arm_group_label>
    <other_name>Group 3</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Part 2 Group 4</intervention_name>
    <description>300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)</description>
    <arm_group_label>Part 2 Group 4</arm_group_label>
    <other_name>Group 4</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male and female subjects, between 18 and 54 years of age (inclusive).&#xD;
&#xD;
          2. Subjects who are able and willing to give written informed consent.&#xD;
&#xD;
          3. Body mass index (BMI) between 28.0 and 40.0 kg/m² (inclusive). Weight on Day -1 may&#xD;
             not have changed by more than 3 kg compared to screening.&#xD;
&#xD;
          4. Compressed STMD of 10 mm and above (Part 1+2).&#xD;
&#xD;
          5. Non-smoker for at least 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Receipt of medication (prescription or non-prescription) within 14 days prior to the&#xD;
             planned drug administration, except for occasional use of paracetamol or ibuprofen.&#xD;
&#xD;
          2. Receipt of any of the following medications within the previous 6 months; beta&#xD;
             adrenergic blockers, tricyclic antidepressants, monoamine oxidase inhibitors and&#xD;
             catechol-O-methyl transferase inhibitors, methylphenidate, amphetamines, any drugs&#xD;
             that may sensitize the heart to arrhythmias, including digitalis and quinidine.&#xD;
&#xD;
          3. History or current evidence of a clinically significant disease including, but not&#xD;
             limited to: cardiovascular, hepatic, renal, hematological, neuropsychological,&#xD;
             endocrine, gastrointestinal or pulmonary diseases especially asthma bronchiale.&#xD;
             Significant is defined as any disease that, in the opinion of the investigator, would&#xD;
             put the safety of the subject at risk through participation, or which could affect the&#xD;
             endpoint analysis if the disease/condition exacerbated during the study.&#xD;
&#xD;
             History or presence of silent infections, including positive tests for HIV1, HIV2,&#xD;
             Hepatitis B or C.&#xD;
&#xD;
          4. Presence of any disease or condition known to interfere with the absorption,&#xD;
             distribution, metabolism or excretion of drugs.&#xD;
&#xD;
          5. Hypersensitivity to epinephrine or any of the excipients (e.g. metabisulphite).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>54 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beate Klaus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baush and Lomb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nuvisan GmbH</name>
      <address>
        <city>Neu-Ulm</city>
        <state>Wegenerstrasse 13</state>
        <zip>89231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>June 20, 2019</last_update_submitted>
  <last_update_submitted_qc>June 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anaphylaxis</mesh_term>
  </condition_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/NCT03282929
org study id: N-A-PH1-15-050
nct id: NCT03282929
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and
      pharmacodynamics of epinephrine in healthy male and female subjects
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and
      pharmacodynamics of epinephrine in healthy male and female subjects with different
      skin-to-muscle depth (STMD) of the thigh after injections with four different marketed
      auto-injectors
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin-to-muscle depth (STMD) of the thigh after injections with four different marketed auto-injectors
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax
time frame: 14 days
description: Maximum observed drug concentration
measure: tmax
time frame: 14 days
description: Time of the maximum drug concentration (obtained without interpolation). If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
arm group label: Part 1 Group 1
arm group type: Experimental
description: A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order.
arm group label: Part 2 group 1
arm group type: Experimental
description: 300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
arm group label: Part 2 Group 2
arm group type: Experimental
description: 500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
arm group label: Part 2 Group 3
arm group type: Experimental
description: 300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)
arm group label: Part 2 Group 4
arm group type: Experimental
description: 300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)
intervention type: Device
intervention name: Part 1
description: A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order
arm group label: Part 1 Group 1
other name: Group 1
intervention type: Device
intervention name: Part 2 Group 1
description: 300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
arm group label: Part 2 group 1
other name: Group 1
intervention type: Drug
intervention name: Part 2 group 2
description: 500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
arm group label: Part 2 Group 2
other name: Group 2
intervention type: Device
intervention name: Part 2 group 3
description: 300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)
arm group label: Part 2 Group 3
other name: Group 3
intervention type: Device
intervention name: Part 2 Group 4
description: 300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)
arm group label: Part 2 Group 4
other name: Group 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 54 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Beate Klaus, MD
role: Principal Investigator
affiliation: Baush and Lomb
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Anaphylaxis