<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/NCT03032315</url>
  </required_header>
  <id_info>
    <org_study_id>ID-TAH-103</org_study_id>
    <nct_id>NCT03032315</nct_id>
  </id_info>
  <brief_title>Compare the Pharmacokinetics of TAH(80/10/12.5) Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers</brief_title>
  <official_title>Clinical Trial to Compare the Pharmacokinetics of TAH Tablet(80/10/12.5mg) in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IlDong Pharmaceutical Co Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IlDong Pharmaceutical Co Ltd</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>
      randomized, open-label, single dose, replicate crossover clinical trial to compare the&#xD;
      pharmacokinetics of TAH(80/10/12.5) tablet in comparison to the co-administration of&#xD;
      telmisartan, amlodipine and hydrochlorothiazide in healthy male volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">December 27, 2016</completion_date>
  <primary_completion_date type="Actual">December 27, 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUClast</measure>
    <time_frame>[Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144(Total 18 points)]</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>[Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144 (Total 18 points)]</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>TAH(80/10/12.5) tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telmisartan/Amlodipine besylate/Hydrochlorothiazide(80/10/12.5) tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telmisartan+Amlodipine besylate+Hydrochlorothiazide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>coadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAH Tablet (Telmisartan80/Amlodipine besylate10/Hydrochlorothiazide12.5)</intervention_name>
    <description>Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 12.5 mg combination-drug would be administered orally once</description>
    <arm_group_label>TAH(80/10/12.5) tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TWYNSTA(Telmisartan+Amlodipine besylate)</intervention_name>
    <description>TWYNSTA 2 Tab. 40/5mg(Telmisartan 40 mg, Amlodipine besylate 6.935 mg(Amlodipine 5 mg) would be administered orally once</description>
    <arm_group_label>Telmisartan+Amlodipine besylate+Hydrochlorothiazide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrochlorothiazide</intervention_name>
    <description>Dichlozid 1 Tab.(Hydrochlorothiazide 12.5 mg) would be administered orally once</description>
    <arm_group_label>Telmisartan+Amlodipine besylate+Hydrochlorothiazide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male volunteers aged 19 to 55 years&#xD;
&#xD;
          2. body mass index (BMI) of 17.5-30.5kg/m2 and weigh more than 55kg&#xD;
&#xD;
          3. Subject does not have congenital or chronic disease and is without pathologic symptom&#xD;
             or finding on medical exam.&#xD;
&#xD;
          4. Subject was determined eligible according to the results of clinical laboratory tests&#xD;
             like serum test, hematologic test, blood chemistry test, urine test etc. and vital&#xD;
             signs, electrocardiography, physical exam etc. performed during the screening exam. 5)&#xD;
             willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies at time of dosing)&#xD;
&#xD;
          2. A subject with a history of gastrointestinal disease or surgery (except simple&#xD;
             appendectomy or repair of hernia), which can influence the absorption of the study&#xD;
             drug&#xD;
&#xD;
          3. History of regular alcohol consumption (&gt; 210 g/week) within the 6 months before the&#xD;
             screening visit.&#xD;
&#xD;
          4. Subjects who take the medication involved in other clinical trials or bioequivalence&#xD;
             tests within three months before the first dose medication characters.&#xD;
&#xD;
          5. Seated systolic blood pressure &lt;100mmHg or ≥ 150 mmHg , or diastolic blood pressure of&#xD;
             &lt;600mmHg or ≥ 100mmHg at the screening visit&#xD;
&#xD;
          6. History of alcohol or drug abuse within the 12 months before the screening visit&#xD;
&#xD;
          7. Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals&#xD;
             within 30days prior to the first dosing.&#xD;
&#xD;
          8. Smoker who smoke more than 20 cigarettes per day&#xD;
&#xD;
          9. Subjects who take ethical the count or over the count medicine within 10days before&#xD;
             the first investigational product administration.&#xD;
&#xD;
         10. Blood Subjects who do the whole blood donation within two months or component blood&#xD;
             donation within 1month prior to the first dosing.&#xD;
&#xD;
         11. Subjects who can increase risk due to clinical test and administration of drugs or has&#xD;
             Severe grade / chronic medical, mental condition or abnormal laboratory result that&#xD;
             may interfere with the analysis of test results.&#xD;
&#xD;
         12. Subject with known for hypersensitivity reaction to TWYNSTA TAB or dihydropyridine&#xD;
             derivatives&#xD;
&#xD;
         13. Subject with known for hypersensitivity reaction to thiazide diuretics or Sulfonamides&#xD;
&#xD;
         14. Patients with biliary obstructive disorder&#xD;
&#xD;
         15. Patients receiving other drugs that affect RAAS such as Angiotensin Receptor&#xD;
             Blocker(ARB), ACE inhibitors or aliskiren&#xD;
&#xD;
         16. Combination with aliskiren in Diabetic patient or moderate to severe renal&#xD;
             insufficient subjects (glomerular filtration rate&lt;60mL/min/1.73m2)&#xD;
&#xD;
         17. Patients with severe hepatic impairment&#xD;
&#xD;
         18. Patients with severe aortic stenosis&#xD;
&#xD;
         19. Patients with history of shock&#xD;
&#xD;
         20. Patients with anuria&#xD;
&#xD;
         21. Patients with acute or severe renal failure&#xD;
&#xD;
         22. Patients with hyponatraemia hypokalemia&#xD;
&#xD;
         23. Patients with Addison's disease&#xD;
&#xD;
         24. Patients with hypercalcemia of malignancy&#xD;
&#xD;
         25. Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose&#xD;
             malabsorption or genetic disorders&#xD;
&#xD;
         26. Test subjects who is not willing or unable to comply with guidelines described in this&#xD;
             protocol&#xD;
&#xD;
         27. A person who is not determined unsuitable to participate in this test by the&#xD;
             researchers&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chonbuk National University Hospital</name>
      <address>
        <city>Chonbuk</city>
        <zip>561-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amlodipine</mesh_term>
    <mesh_term>Hydrochlorothiazide</mesh_term>
    <mesh_term>Telmisartan</mesh_term>
    <mesh_term>Telmisartan amlodipine combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03032315
org study id: ID-TAH-103
nct id: NCT03032315
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
randomized, open-label, single dose, replicate crossover clinical trial to compare the
      pharmacokinetics of TAH(80/10/12.5) tablet in comparison to the co-administration of
      telmisartan, amlodipine and hydrochlorothiazide in healthy male volunteers
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUClast
time frame: [Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144(Total 18 points)]
measure: Cmax
time frame: [Time Frame: Hour 0 (Pre-dose), Hour 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144 (Total 18 points)]
arm group label: TAH(80/10/12.5) tablet
arm group type: Experimental
description: Telmisartan/Amlodipine besylate/Hydrochlorothiazide(80/10/12.5) tablet
arm group label: Telmisartan+Amlodipine besylate+Hydrochlorothiazide
arm group type: Active Comparator
description: coadministration of Telmisartan, Amlodipine besylate and Hydrochlorothiazide
intervention type: Drug
intervention name: TAH Tablet (Telmisartan80/Amlodipine besylate10/Hydrochlorothiazide12.5)
description: Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 12.5 mg combination-drug would be administered orally once
arm group label: TAH(80/10/12.5) tablet
intervention type: Drug
intervention name: TWYNSTA(Telmisartan+Amlodipine besylate)
description: TWYNSTA 2 Tab. 40/5mg(Telmisartan 40 mg, Amlodipine besylate 6.935 mg(Amlodipine 5 mg) would be administered orally once
arm group label: Telmisartan+Amlodipine besylate+Hydrochlorothiazide
intervention type: Drug
intervention name: Hydrochlorothiazide
description: Dichlozid 1 Tab.(Hydrochlorothiazide 12.5 mg) would be administered orally once
arm group label: Telmisartan+Amlodipine besylate+Hydrochlorothiazide
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Amlodipine
mesh term: Hydrochlorothiazide
mesh term: Telmisartan
mesh term: Telmisartan amlodipine combination
sharing ipd: Undecided