<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/NCT02982889</url>
  </required_header>
  <id_info>
    <org_study_id>LTI-111</org_study_id>
    <secondary_id>2016-002420-88</secondary_id>
    <nct_id>NCT02982889</nct_id>
  </id_info>
  <brief_title>Single Ascending Dose Study of Two Liquidia Bupivacaine Formulations</brief_title>
  <official_title>A Phase 1 Randomized, Controlled, Double-Blind, Single Ascending Dose Safety and Pharmacokinetic/Pharmacodynamic Study in Healthy Adult Males After LIQ865 Injection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liquidia Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Premier Research Group plc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Liquidia Technologies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess and characterize the safety and tolerability profile of&#xD;
      LIQ865A and LIQ865B formulations compared to diluent or aqueous bupivacaine hydrochloride&#xD;
      when infiltrated into a defined area of the medial calf, and to characterize bupivacaine&#xD;
      plasma pharmacokinetic (PK) and pharmacodynamic (PD) profiles after a single dose of LIQ865A&#xD;
      or LIQ865B, and to determine the individual plasma concentration/time curves and mean PK&#xD;
      parameters of each product.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infiltration of an aqueous local anesthetic, for example, bupivacaine, into surgical sites at&#xD;
      closure provides temporary analgesia, typically lasting up to 6 hours, and is one aspect of&#xD;
      the multimodal approach to postsurgical analgesia or fast-track surgery. However, the limited&#xD;
      duration of action of local anesthetics, even longer acting agents such as bupivacaine,&#xD;
      result in patients who are likely to experience end of duration breakthrough pain before they&#xD;
      are able to take or tolerate oral analgesics, thus necessitating the use of strong parenteral&#xD;
      analgesics in the immediate postsurgical period. LIQ865A and LIQ865B are two distinct&#xD;
      formulations of bupivacaine manufactured via Liquidia Technologies PRINT (Particle&#xD;
      Replication In Non-wetting Templates), which Liquidia intends to pursue for product approval.&#xD;
      Both formulations being tested have the potential for producing long-lasting control of&#xD;
      post-surgical incisional pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">April 26, 2017</completion_date>
  <primary_completion_date type="Actual">March 23, 2017</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>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment Emergent Adverse Events (AEs)</measure>
    <time_frame>30 days</time_frame>
    <description>Safety assessments will include the incidence and severity of AEs during treatment and the follow-up period of the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic - Area under the plasma concentration curve from time zero to Day 5</measure>
    <time_frame>Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic - Cmax (ng/mL)</measure>
    <time_frame>Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment</time_frame>
    <description>Maximum plasma concentration over the entire sampling period, directly obtained from the experimental data of plasma concentration versus time curves, without interpolation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic - Tmax (h)</measure>
    <time_frame>Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment</time_frame>
    <description>Time to reach maximum plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic - t1/2 (h)</measure>
    <time_frame>Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment</time_frame>
    <description>Apparent terminal elimination half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic - CST1/2 (h)</measure>
    <time_frame>Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment</time_frame>
    <description>Context-sensitive half-time measured from Tmax to time for plasma concentration to reach half of Cmax following study medication injection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Response - Pain intensity (Numeric Rating Scale) with Short Tonic Heat Stimulus (STHS) testing at various time points</measure>
    <time_frame>1, 2, 12, 24, 48, 72, 96, and 120 hours</time_frame>
    <description>Testing done to calculate time-weighted Sum of Pain Intensity Differences (SPID) at the time points noted, compared to Baseline, and time specific SPID results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Response - Change in Mechanical Pain Threshold (MPT) compared to Baseline using various time points</measure>
    <time_frame>12, 24, 48, 72, 96, and 120 hours</time_frame>
    <description>Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Response - Change in Heat Pain Threshold (HPT) compared to Baseline using various time points</measure>
    <time_frame>12, 24, 48, 72, 96, and 120 hours</time_frame>
    <description>Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Response - Change Mechanical Detection Threshold (MDT) compared to Baseline using various time points</measure>
    <time_frame>12, 24, 48, 72, 96, and 120 hours</time_frame>
    <description>Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Response - Change in Warmth Detection Threshold (WDT) compared to Baseline using various time points</measure>
    <time_frame>12, 24, 48, 72, 96, and 120 hours</time_frame>
    <description>Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Response - Change in Cold Detection Threshold (CDT) compared to Baseline using various time points</measure>
    <time_frame>12, 24, 48, 72, 96, and 120 hours</time_frame>
    <description>Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>LIQ865A bupivacaine formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Liquidia's PRINT bupivacaine free base/PLGA (poly D,L-lactic-co-glycolic acid) suspension for subcutaneous injection at doses ranging from 150mg to 600mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LIQ865B bupivacaine formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Liquidia's PRINT bupivacaine free base suspension for subcutaneous injection at doses ranging from 150mg to 600mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diluent for LIQ865</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Negative control for subcutaneous injection. Each subject will act as his own control, receiving a LIQ865 formulation subcutaneous injection in one calf, and a diluent subcutaneous injection in his other calf</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.5% bupivacaine hydrochoride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Positive control arm to be used with one of the LIQ865 cohorts, with each subject acting as his own positive control (i.e., one leg will receive subcutaneous injection of LIQ865A or LIQ865B, and the other leg will receive subcutaneous injection of 0.5% bupivacaine hydrochloride).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LIQ865A bupivacaine formulation</intervention_name>
    <description>single subcutaneous injection in medial calf</description>
    <arm_group_label>0.5% bupivacaine hydrochoride</arm_group_label>
    <arm_group_label>Diluent for LIQ865</arm_group_label>
    <arm_group_label>LIQ865A bupivacaine formulation</arm_group_label>
    <other_name>Marcaine</other_name>
    <other_name>Marcaine Spinal</other_name>
    <other_name>Sensorcaine</other_name>
    <other_name>Sensorcaine-MPF</other_name>
    <other_name>Sensorcaine-MPF Spinal</other_name>
    <other_name>Marcaine HCl</other_name>
    <other_name>Exparel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LIQ865B bupivacaine formulation</intervention_name>
    <description>single subcutaneous injection in medial calf</description>
    <arm_group_label>0.5% bupivacaine hydrochoride</arm_group_label>
    <arm_group_label>Diluent for LIQ865</arm_group_label>
    <arm_group_label>LIQ865B bupivacaine formulation</arm_group_label>
    <other_name>Marcaine</other_name>
    <other_name>Marcaine Spinal</other_name>
    <other_name>Sensorcaine</other_name>
    <other_name>Sensorcaine-MPF</other_name>
    <other_name>Sensorcaine-MPF Spinal</other_name>
    <other_name>Marcaine HCl</other_name>
    <other_name>Exparel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diluent for LIQ865</intervention_name>
    <description>Sterile diluent composed of 12.5mg/g sodium hyaluronate, 5.8mg/g sodium chloride, 1mg/g polysorbate 80, 6.1mg/g Tris base, in sterile water for injection - single subcutaneous injection</description>
    <arm_group_label>Diluent for LIQ865</arm_group_label>
    <arm_group_label>LIQ865A bupivacaine formulation</arm_group_label>
    <arm_group_label>LIQ865B bupivacaine formulation</arm_group_label>
    <other_name>Hyaluronic Acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.5% bupivacaine hydrochoride</intervention_name>
    <description>single subcutaneous injection</description>
    <arm_group_label>0.5% bupivacaine hydrochoride</arm_group_label>
    <other_name>Marcaine</other_name>
    <other_name>Marcaine Spinal</other_name>
    <other_name>Sensorcaine</other_name>
    <other_name>Sensorcaine-MPF</other_name>
    <other_name>Sensorcaine-MPF Spinal</other_name>
    <other_name>Marcaine HCl</other_name>
    <other_name>Exparel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  provide written informed consent prior to enrollment&#xD;
&#xD;
          -  be a non-smoking male, American Society of Anesthesiologist (ASA) physical class 1 or&#xD;
             2&#xD;
&#xD;
          -  have a BMI between 18.5 and 25 kg. inclusive, and a weight of at least 60 kg&#xD;
&#xD;
          -  be willing and able to participate for the duration of the study&#xD;
&#xD;
          -  be healthy on the basis of pre-study physical examination (PE), medical history&#xD;
             review, vital signs, lab test results as specified in the protocol&#xD;
&#xD;
          -  negative urine drug test results&#xD;
&#xD;
          -  negative alcohol screening test&#xD;
&#xD;
          -  negative antibody test results for hepatitis B, hepatitis C, and HIV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergic to bupivacaine, or other amide local anesthetics, or the excipients in the&#xD;
             LIQ865 formulations or the diluent&#xD;
&#xD;
          -  has taken any concomitant medications or supplements for the 3 days prior to Day 0&#xD;
&#xD;
          -  has been on blood thinner or medication affecting platelet formation for the 7 days&#xD;
             prior to Day 0&#xD;
&#xD;
          -  in the opinion of the investigator, is either a hyper or hypo-responder to screening&#xD;
             sensitivity testing&#xD;
&#xD;
          -  has a history of moderate or severe renal or hepatic impairment, moderate or severe&#xD;
             active hepatic disease, or any other clinically significant medical condition that may&#xD;
             preclude safe study participation&#xD;
&#xD;
          -  has a clinically significant test result for any screening lab parameter&#xD;
&#xD;
          -  has a history or ECG screening documentation of a clinically meaningful conduction&#xD;
             abnormality&#xD;
&#xD;
          -  has scarring, tattoos, infections, or other skin changes in the area of planned study&#xD;
             medication injection&#xD;
&#xD;
          -  has known neurological disease or dysfunction (central or peripheral) that may&#xD;
             interfere with assessments&#xD;
&#xD;
          -  is unable to adequately communicate with study staff, properly give informed consent,&#xD;
             or otherwise comply with study procedures, particularly the ability to return for&#xD;
             outpatient follow up visits&#xD;
&#xD;
          -  has participated in another interventional clinical study (investigational or marketed&#xD;
             product) within the 30 days prior to Day 0.&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Mads U Werner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Multidisciplinary Pain Center, Rigshospitalet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DanTrial Aps</name>
      <address>
        <city>Copenhagen</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Analytical, Diagnostic,Therapeutic Technique and Equipment</keyword>
  <keyword>Anesthesia and Analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02982889
org study id: LTI-111
secondary id: 2016-002420-88
nct id: NCT02982889
lead sponsor: 
collaborator: 
has dmc: No
This study is designed to assess and characterize the safety and tolerability profile of
      LIQ865A and LIQ865B formulations compared to diluent or aqueous bupivacaine hydrochloride
      when infiltrated into a defined area of the medial calf, and to characterize bupivacaine
      plasma pharmacokinetic (PK) and pharmacodynamic (PD) profiles after a single dose of LIQ865A
      or LIQ865B, and to determine the individual plasma concentration/time curves and mean PK
      parameters of each product.
Infiltration of an aqueous local anesthetic, for example, bupivacaine, into surgical sites at
      closure provides temporary analgesia, typically lasting up to 6 hours, and is one aspect of
      the multimodal approach to postsurgical analgesia or fast-track surgery. However, the limited
      duration of action of local anesthetics, even longer acting agents such as bupivacaine,
      result in patients who are likely to experience end of duration breakthrough pain before they
      are able to take or tolerate oral analgesics, thus necessitating the use of strong parenteral
      analgesics in the immediate postsurgical period. LIQ865A and LIQ865B are two distinct
      formulations of bupivacaine manufactured via Liquidia Technologies PRINT (Particle
      Replication In Non-wetting Templates), which Liquidia intends to pursue for product approval.
      Both formulations being tested have the potential for producing long-lasting control of
      post-surgical incisional pain.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of Treatment Emergent Adverse Events (AEs)
time frame: 30 days
description: Safety assessments will include the incidence and severity of AEs during treatment and the follow-up period of the study
measure: Pharmacokinetic - Area under the plasma concentration curve from time zero to Day 5
time frame: Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment
measure: Pharmacokinetic - Cmax (ng/mL)
time frame: Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment
description: Maximum plasma concentration over the entire sampling period, directly obtained from the experimental data of plasma concentration versus time curves, without interpolation.
measure: Pharmacokinetic - Tmax (h)
time frame: Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment
description: Time to reach maximum plasma concentration
measure: Pharmacokinetic - t1/2 (h)
time frame: Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment
description: Apparent terminal elimination half-life
measure: Pharmacokinetic - CST1/2 (h)
time frame: Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment
description: Context-sensitive half-time measured from Tmax to time for plasma concentration to reach half of Cmax following study medication injection.
measure: Pharmacodynamic Response - Pain intensity (Numeric Rating Scale) with Short Tonic Heat Stimulus (STHS) testing at various time points
time frame: 1, 2, 12, 24, 48, 72, 96, and 120 hours
description: Testing done to calculate time-weighted Sum of Pain Intensity Differences (SPID) at the time points noted, compared to Baseline, and time specific SPID results
measure: Pharmacodynamic Response - Change in Mechanical Pain Threshold (MPT) compared to Baseline using various time points
time frame: 12, 24, 48, 72, 96, and 120 hours
description: Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120
measure: Pharmacodynamic Response - Change in Heat Pain Threshold (HPT) compared to Baseline using various time points
time frame: 12, 24, 48, 72, 96, and 120 hours
description: Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120
measure: Pharmacodynamic Response - Change Mechanical Detection Threshold (MDT) compared to Baseline using various time points
time frame: 12, 24, 48, 72, 96, and 120 hours
description: Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120
measure: Pharmacodynamic Response - Change in Warmth Detection Threshold (WDT) compared to Baseline using various time points
time frame: 12, 24, 48, 72, 96, and 120 hours
description: Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120
measure: Pharmacodynamic Response - Change in Cold Detection Threshold (CDT) compared to Baseline using various time points
time frame: 12, 24, 48, 72, 96, and 120 hours
description: Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120
arm group label: LIQ865A bupivacaine formulation
arm group type: Experimental
description: Liquidia's PRINT bupivacaine free base/PLGA (poly D,L-lactic-co-glycolic acid) suspension for subcutaneous injection at doses ranging from 150mg to 600mg
arm group label: LIQ865B bupivacaine formulation
arm group type: Experimental
description: Liquidia's PRINT bupivacaine free base suspension for subcutaneous injection at doses ranging from 150mg to 600mg
arm group label: Diluent for LIQ865
arm group type: Placebo Comparator
description: Negative control for subcutaneous injection. Each subject will act as his own control, receiving a LIQ865 formulation subcutaneous injection in one calf, and a diluent subcutaneous injection in his other calf
arm group label: 0.5% bupivacaine hydrochoride
arm group type: Active Comparator
description: Positive control arm to be used with one of the LIQ865 cohorts, with each subject acting as his own positive control (i.e., one leg will receive subcutaneous injection of LIQ865A or LIQ865B, and the other leg will receive subcutaneous injection of 0.5% bupivacaine hydrochloride).
intervention type: Drug
intervention name: LIQ865A bupivacaine formulation
description: single subcutaneous injection in medial calf
arm group label: 0.5% bupivacaine hydrochoride
arm group label: Diluent for LIQ865
arm group label: LIQ865A bupivacaine formulation
other name: Marcaine
other name: Marcaine Spinal
other name: Sensorcaine
other name: Sensorcaine-MPF
other name: Sensorcaine-MPF Spinal
other name: Marcaine HCl
other name: Exparel
intervention type: Drug
intervention name: LIQ865B bupivacaine formulation
description: single subcutaneous injection in medial calf
arm group label: 0.5% bupivacaine hydrochoride
arm group label: Diluent for LIQ865
arm group label: LIQ865B bupivacaine formulation
other name: Marcaine
other name: Marcaine Spinal
other name: Sensorcaine
other name: Sensorcaine-MPF
other name: Sensorcaine-MPF Spinal
other name: Marcaine HCl
other name: Exparel
intervention type: Drug
intervention name: Diluent for LIQ865
description: Sterile diluent composed of 12.5mg/g sodium hyaluronate, 5.8mg/g sodium chloride, 1mg/g polysorbate 80, 6.1mg/g Tris base, in sterile water for injection - single subcutaneous injection
arm group label: Diluent for LIQ865
arm group label: LIQ865A bupivacaine formulation
arm group label: LIQ865B bupivacaine formulation
other name: Hyaluronic Acid
intervention type: Drug
intervention name: 0.5% bupivacaine hydrochoride
description: single subcutaneous injection
arm group label: 0.5% bupivacaine hydrochoride
other name: Marcaine
other name: Marcaine Spinal
other name: Sensorcaine
other name: Sensorcaine-MPF
other name: Sensorcaine-MPF Spinal
other name: Marcaine HCl
other name: Exparel
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mads U Werner, MD
role: Principal Investigator
affiliation: Multidisciplinary Pain Center, Rigshospitalet
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Acute Pain
mesh term: Bupivacaine
mesh term: Hyaluronic Acid
sharing ipd: No