<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/NCT03777605</url>
  </required_header>
  <id_info>
    <org_study_id>Nitroglycerine1523 (NTG1523)</org_study_id>
    <nct_id>NCT03777605</nct_id>
  </id_info>
  <brief_title>Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation</brief_title>
  <official_title>Absorption and Pharmacokinetics of Nitroglycerin as a Tablet or in the Form of Rapidly Degradable Capsule in Young Healthy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kolding Sygehus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kolding Sygehus</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>
      The study evaluate the absorption rate of different sublingual formulation of nitroglycerine&#xD;
      (NTG) either in the form of available tablets or a new rapid absorbable gelation capsule&#xD;
      formulation &quot;NTG1523&quot; by determining T-max and area under the response curve of nitoglycerine&#xD;
      in blood concentration as well as from clinical effects after intake. Data is entered on data&#xD;
      sheet in anonymous form and processed. The results are presented in anonymous form by&#xD;
      publication and lecture. Experts are given the supplement: &quot;The applicant's rights in a&#xD;
      biomedical research project&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ten healthy young volunteers are recruited,, and the experiments begin at 07:45 after an&#xD;
      overneight fast. BMI and blod pressure are recorded and a catheter is inserted in an&#xD;
      anticubical vein for blood samples.&#xD;
&#xD;
      At 08.00 a sublingual tablet (Takeda, nitroglycerin 0.4 milligrams) tablet or a &quot;NTG1523&quot;&#xD;
      capsule with 0.4 milligrams of nitroglycerine is placed under the tongue in random order.&#xD;
      Subsequently, blood samples are taken every minute for 10 minutes, then every 10 minutes the&#xD;
      following two hours. In addition, blood pressure and puls rate are measured every second&#xD;
      minute the first ten minutes, and then every 10 minutes.Side effects and time to the&#xD;
      participants registrate any effect of the drugs are assessed in a prefabricated scheme.&#xD;
&#xD;
      The disadvantages associated with the experiment are sought monitored by adverse event&#xD;
      registration which ends at the end of the trial. The trial day lasts 2 hours in which blood&#xD;
      samples are taken as described above, and blood pressure and records are stored .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 23, 2018</start_date>
  <completion_date type="Anticipated">December 23, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 5, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A randomized, cross over design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>All tablets are processed, marked and coded by a pharmacist,</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration of Nitroglycerine as a tablet or in the form of rapidly degradable capsule &quot;NTG1523&quot; in young healthy controls</measure>
    <time_frame>From 2 weeks up til 5 weeks</time_frame>
    <description>Peak Plasma Concentration (Cmax)(ng(ml) of nitroglycerine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure in response to Nitroglycerine</measure>
    <time_frame>From 2 weeks up til 5 weeks</time_frame>
    <description>Blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Puls rate in response to Nitroglycerine</measure>
    <time_frame>From 2 weeks up til 5 weeks</time_frame>
    <description>puls rate (beat/min)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Angina Pectoris</condition>
  <arm_group>
    <arm_group_label>&quot;NTG1523&quot;, rapid absorbable capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nitroglycerine 0.4 milligram taken as ordinary tablets or &quot;NTG1523&quot; rapid absorbable capsule once in the morning, and subsequently blood samples and observations for 2 hours are performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitroglycerin 0.4 MG</intervention_name>
    <description>The study evaluate absorption rate of nitroglycerine 0.4 milligrams as tablets or a quickly absorbable capsuel &quot;NTG1523&quot; determined by T-max and area under the response curve in the blood of NTG as well as from clinical effects.&#xD;
Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: &quot;The applicant's rights in a biomedical research project</description>
    <arm_group_label>&quot;NTG1523&quot;, rapid absorbable capsule</arm_group_label>
    <other_name>&quot;NTG1523&quot;</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal healthy volunteers&#xD;
&#xD;
          -  Must be able to swallow tablets&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insulin dependent diabetes&#xD;
&#xD;
          -  Thyroid disease&#xD;
&#xD;
          -  any medial treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>28 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ole W Rasmussen, M.D. Dr.Sci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Dept.,Kolding Hospital, SLB, Denmark</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ole W Rasmussen, M.D., Dr.Sci</last_name>
    <phone>+4550506930</phone>
    <email>olew.rasmussen@dadlnet.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Poul H Madsen, M.D., Ph.D.</last_name>
    <phone>+45 76362000</phone>
    <email>Poul.Henning.Madsen@rsyd.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kolfding Sygehus, SLB</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Nakashima E, Rigod JF, Lin ET, Benet LZ. Pharmacokinetics of nitroglycerin and its dinitrate metabolites over a thirtyfold range of oral doses. Clin Pharmacol Ther. 1990 May;47(5):592-8. doi: 10.1038/clpt.1990.80.</citation>
    <PMID>2111749</PMID>
  </reference>
  <results_reference>
    <citation>McAllister A, Mosberg H, Settlage JA, Steiner JA. Plasma levels of nitroglycerin generated by three nitroglycerin patch preparations, Nitradisc, Transiderm-Nitro and Nitro-Dur and one ointment formulation, Nitrobid. Br J Clin Pharmacol. 1986 Apr;21(4):365-9. doi: 10.1111/j.1365-2125.1986.tb05208.x.</citation>
    <PMID>3085698</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kolding Sygehus</investigator_affiliation>
    <investigator_full_name>Ole Winther Rasmussen</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angina Pectoris</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitroglycerin</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/NCT03777605
org study id: Nitroglycerine1523 (NTG1523)
nct id: NCT03777605
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluate the absorption rate of different sublingual formulation of nitroglycerine
      (NTG) either in the form of available tablets or a new rapid absorbable gelation capsule
      formulation "NTG1523" by determining T-max and area under the response curve of nitoglycerine
      in blood concentration as well as from clinical effects after intake. Data is entered on data
      sheet in anonymous form and processed. The results are presented in anonymous form by
      publication and lecture. Experts are given the supplement: "The applicant's rights in a
      biomedical research project
Ten healthy young volunteers are recruited,, and the experiments begin at 07:45 after an
      overneight fast. BMI and blod pressure are recorded and a catheter is inserted in an
      anticubical vein for blood samples.

      At 08.00 a sublingual tablet (Takeda, nitroglycerin 0.4 milligrams) tablet or a "NTG1523"
      capsule with 0.4 milligrams of nitroglycerine is placed under the tongue in random order.
      Subsequently, blood samples are taken every minute for 10 minutes, then every 10 minutes the
      following two hours. In addition, blood pressure and puls rate are measured every second
      minute the first ten minutes, and then every 10 minutes.Side effects and time to the
      participants registrate any effect of the drugs are assessed in a prefabricated scheme.

      The disadvantages associated with the experiment are sought monitored by adverse event
      registration which ends at the end of the trial. The trial day lasts 2 hours in which blood
      samples are taken as described above, and blood pressure and records are stored .
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A randomized, cross over design
primary purpose: Treatment
masking: None (Open Label)
masking description: All tablets are processed, marked and coded by a pharmacist,
measure: Peak Plasma Concentration of Nitroglycerine as a tablet or in the form of rapidly degradable capsule "NTG1523" in young healthy controls
time frame: From 2 weeks up til 5 weeks
description: Peak Plasma Concentration (Cmax)(ng(ml) of nitroglycerine
measure: Blood pressure in response to Nitroglycerine
time frame: From 2 weeks up til 5 weeks
description: Blood pressure (mmHg)
measure: Puls rate in response to Nitroglycerine
time frame: From 2 weeks up til 5 weeks
description: puls rate (beat/min)
arm group label: "NTG1523", rapid absorbable capsule
arm group type: Experimental
description: Nitroglycerine 0.4 milligram taken as ordinary tablets or "NTG1523" rapid absorbable capsule once in the morning, and subsequently blood samples and observations for 2 hours are performed
intervention type: Drug
intervention name: Nitroglycerin 0.4 MG
description: The study evaluate absorption rate of nitroglycerine 0.4 milligrams as tablets or a quickly absorbable capsuel "NTG1523" determined by T-max and area under the response curve in the blood of NTG as well as from clinical effects.
Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project
arm group label: "NTG1523", rapid absorbable capsule
other name: "NTG1523"
criteria: 
gender: All
minimum age: 18 Years
maximum age: 28 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ole W Rasmussen, M.D. Dr.Sci
role: Principal Investigator
affiliation: Medical Dept.,Kolding Hospital, SLB, Denmark
last name: ole W Rasmussen, M.D., Dr.Sci
phone: +4550506930
email: olew.rasmussen@dadlnet.dk
last name: Poul H Madsen, M.D., Ph.D.
phone: +45 76362000
email: Poul.Henning.Madsen@rsyd.dk
facility: 
country: Denmark
citation: Nakashima E, Rigod JF, Lin ET, Benet LZ. Pharmacokinetics of nitroglycerin and its dinitrate metabolites over a thirtyfold range of oral doses. Clin Pharmacol Ther. 1990 May;47(5):592-8. doi: 10.1038/clpt.1990.80.
PMID: 2111749
citation: McAllister A, Mosberg H, Settlage JA, Steiner JA. Plasma levels of nitroglycerin generated by three nitroglycerin patch preparations, Nitradisc, Transiderm-Nitro and Nitro-Dur and one ointment formulation, Nitrobid. Br J Clin Pharmacol. 1986 Apr;21(4):365-9. doi: 10.1111/j.1365-2125.1986.tb05208.x.
PMID: 3085698
responsible party type: Principal Investigator
investigator affiliation: Kolding Sygehus
investigator full name: Ole Winther Rasmussen
investigator title: Clinical professor
mesh term: Angina Pectoris
mesh term: Nitroglycerin
sharing ipd: No