<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/NCT04485585</url>
  </required_header>
  <id_info>
    <org_study_id>BR-TMC-CT-101</org_study_id>
    <nct_id>NCT04485585</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.</brief_title>
  <official_title>An Open Label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boryung Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boryung 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>
      To evaluate the influence of BR9006-1 and BR9006-2 on pharmacokinetics, safety, and&#xD;
      tolerability when administered separately or co-administered to healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 36 subjects will be enrolled in one sequence group. The investigational products&#xD;
      will be administered according to the treatment groups (T, M, T+M) assigned to one sequence&#xD;
      group in Period 1, Period 2, and Period 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">August 26, 2020</completion_date>
  <primary_completion_date type="Actual">August 16, 2020</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic variables - Maximum (peak) steady-state plasma drug concentration during a dosage interval(Cmax,ss) of Part A and B</measure>
    <time_frame>0~26 days after medication</time_frame>
    <description>The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic variables - Area under the plasma concentration-time curve from time zero to time t(AUCt) of Part A and B</measure>
    <time_frame>0~26 days after medication</time_frame>
    <description>The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic variables - Time to reach maximum (peak) plasma concentration following drug administration at steady state (Tmax,ss) of Part A and B</measure>
    <time_frame>0~26 days after medication</time_frame>
    <description>The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic variables - Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss) of Part A and B</measure>
    <time_frame>0~26 days after medication</time_frame>
    <description>The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Benign Prostatic Hyperplasia (BPH)</condition>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>Sequence T/M/T+M</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A total of 36 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(T, M, T+M) assigned to on sequence group in Period 1, Period 2, and Period 3.&#xD;
Period 1(T): BR9006-1 (Tamsulosin HCL 0.2mg) - 1 capsule QD, five-day repeated-dose&#xD;
Period 2(M): BR9006-2 (Mirabegron 50mg) - 1 tablet QD, eleven-day repeated-dose&#xD;
Period 3(T+M): BR9006-1 (Tamsulosin HCL 0.2mg) 1 capsule + BR9006-2 (Mirabegron 50mg) 1 tablet QD, five-day repeated-dose&#xD;
Washout period between Period 1 and Period 2: five days&#xD;
Washout period between Period 2 and Period 3: none</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BR9006-1</intervention_name>
    <description>Administration to the T/T+M group: 0.2 mg of BR9006-1 will be administered one capsule once a day, five-day repeated-dose</description>
    <arm_group_label>Sequence T/M/T+M</arm_group_label>
    <other_name>Tamsulosin HCL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BR9006-2</intervention_name>
    <description>Administration to the M group: 50 mg of BR9006-2 will be administered one tablet once a day, eleven-day repeated-dose&#xD;
Administration to the T+M group: 50 mg of BR9006-2 will be administered one tablet once a day, five-day repeated-dose</description>
    <arm_group_label>Sequence T/M/T+M</arm_group_label>
    <other_name>Mirabegron</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects are given sufficient explanations about the trial objectives and contents as&#xD;
             well as properties of investigational drugs before participating in the trial, and&#xD;
             will voluntarily express their consent by signing an IRB-approved written consent to&#xD;
             participate in the trial.&#xD;
&#xD;
          2. Healthy male adults aged 19 to 55 years at screening.&#xD;
&#xD;
          3. The subject's weight is 50kg or more and body mass index (BMI) is 18.0 or more but&#xD;
             30.0 or less.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those who have history of clinically significant diseases including hypersensitivity&#xD;
             reaction, intolerability and anaphylaxis to major ingredients (Tamsulosin and&#xD;
             Mirabegron) and other ingredients of investigational products, Food Yellow No. 5&#xD;
             (Sunset Yellow FCF) or Sulfonamide.&#xD;
&#xD;
          2. Those who have a history of clinically significant diseases related to liver, kidney,&#xD;
             digestive system, respiratory system, musculoskeletal system, endocrine system,&#xD;
             neuropsychiatric system, hemato-oncology system, cardiovascular system (including&#xD;
             orthostatic hypotension), etc.&#xD;
&#xD;
          3. Those who have medical history of gastrointestinal system diseases (for example:&#xD;
             Crohn's disease, peptic ulcer disease, etc.) and operations that may influence the&#xD;
             absorption of investigational drugs. (However, appendectomy, hernia operation,&#xD;
             endoscopic polypectomy and hemorrhoids/anal fissure/anal fistula surgeries are&#xD;
             excluded.)&#xD;
&#xD;
          4. Those with abnormal findings from the screening tests (medical interview, vital signs,&#xD;
             electrocardiography, physical checkup, blood test, urinalysis, etc.) are judged to&#xD;
             have clinical significance.&#xD;
&#xD;
          5. Those who are positive to HBsAg, HCV Ab, HIV Ab, VDRL tests at screening.&#xD;
&#xD;
          6. Those with any of the following results at screening:&#xD;
&#xD;
               -  AST or ALT &gt; twice the upper limit of normal range&#xD;
&#xD;
               -  T. bilirubin &gt; twice the upper limit of normal range&#xD;
&#xD;
               -  Estimated glomerular filtration rate (e-GFR) &lt; 60 mL/min/1.73m2 (MDRD method&#xD;
                  used)&#xD;
&#xD;
          7. Those with systolic blood pressure &gt; 150 mmHg or &lt; 90 mmHg, or diastolic blood&#xD;
             pressure &gt; 95 mmHg or &lt; 60 mmHg from vital signs at screening.&#xD;
&#xD;
          8. Those who took drugs (prescription drugs, OTC, herbal medicine or nutritional&#xD;
             supplements (vitamins, etc.)) 2 weeks before screening. (However, those may&#xD;
             participate in the trial if their safety and study results are considered to be&#xD;
             unaffected according to the investigator's judgment.)&#xD;
&#xD;
          9. Those who have a drug abuse problem (especially centrally acting drugs including&#xD;
             sleeping pills, centrally acting pain reliever, opiates or psychoactive drugs) or have&#xD;
             a history of drug abuse.&#xD;
&#xD;
         10. Those who have a history of continuous alcohol intake exceeding 21 units/week&#xD;
             (1unit=10g=12.5mL) within 6 months before screening.&#xD;
&#xD;
         11. Those who have smoked more than 10 cigarettes a day within 6 months before screening.&#xD;
&#xD;
         12. Those who have participated in other clinical trials and have been administered with&#xD;
             other investigational drugs 180 days prior to the estimated administration date of&#xD;
             this study's investigational drugs (However, is not applicable if the investigational&#xD;
             drugs from other trials are not administered).&#xD;
&#xD;
         13. Those who have given whole blood 8 weeks before screening, who have given&#xD;
             plasma/platelet 4 weeks before screening or who have not expressed their consent for&#xD;
             blood-donation prohibition between the period from the first administration and 30&#xD;
             days after the final administration of the investigational drugs.&#xD;
&#xD;
         14. Those who have not expressed their consent for diet restrictions (grapefruit, caffeine&#xD;
             in particular) that can influence absorption, distribution, metabolism and excretion&#xD;
             of investigational drugs in the period between 3 days before the first administration&#xD;
             and the last visit.&#xD;
&#xD;
         15. Those who have not expressed their consent for using contraceptive measures (for&#xD;
             example: contraceptive administration and implant or intrauterine devices,&#xD;
             sterilization (vasectomy, tubal ligation, etc.)) and barrier methods (combined use of&#xD;
             spermicides and condom, contraceptive vaginal diaphragm, contraceptive sponge or&#xD;
             cervical cap) that are allowed for clinical trials in the period between the first&#xD;
             administration of the investigational drugs and the last visit.&#xD;
&#xD;
         16. Others who are judged to be ineligible to participate in the trial by the&#xD;
             investigator.&#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>
  <overall_official>
    <last_name>An-Hye Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHA University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHA Bundang Medical Center, CHA University</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13520</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>October 27, 2020</last_update_submitted>
  <last_update_submitted_qc>October 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2020</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>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</mesh_term>
    <mesh_term>Mirabegron</mesh_term>
  </intervention_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/NCT04485585
org study id: BR-TMC-CT-101
nct id: NCT04485585
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the influence of BR9006-1 and BR9006-2 on pharmacokinetics, safety, and
      tolerability when administered separately or co-administered to healthy male volunteers.
A total of 36 subjects will be enrolled in one sequence group. The investigational products
      will be administered according to the treatment groups (T, M, T+M) assigned to one sequence
      group in Period 1, Period 2, and Period 3.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic variables - Maximum (peak) steady-state plasma drug concentration during a dosage interval(Cmax,ss) of Part A and B
time frame: 0~26 days after medication
description: The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
measure: Pharmacokinetic variables - Area under the plasma concentration-time curve from time zero to time t(AUCt) of Part A and B
time frame: 0~26 days after medication
description: The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
measure: Pharmacokinetic variables - Time to reach maximum (peak) plasma concentration following drug administration at steady state (Tmax,ss) of Part A and B
time frame: 0~26 days after medication
description: The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
measure: Pharmacokinetic variables - Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss) of Part A and B
time frame: 0~26 days after medication
description: The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
arm group label: Sequence T/M/T+M
arm group type: Experimental
description: A total of 36 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(T, M, T+M) assigned to on sequence group in Period 1, Period 2, and Period 3.
Period 1(T): BR9006-1 (Tamsulosin HCL 0.2mg) - 1 capsule QD, five-day repeated-dose
Period 2(M): BR9006-2 (Mirabegron 50mg) - 1 tablet QD, eleven-day repeated-dose
Period 3(T+M): BR9006-1 (Tamsulosin HCL 0.2mg) 1 capsule + BR9006-2 (Mirabegron 50mg) 1 tablet QD, five-day repeated-dose
Washout period between Period 1 and Period 2: five days
Washout period between Period 2 and Period 3: none
intervention type: Drug
intervention name: BR9006-1
description: Administration to the T/T+M group: 0.2 mg of BR9006-1 will be administered one capsule once a day, five-day repeated-dose
arm group label: Sequence T/M/T+M
other name: Tamsulosin HCL
intervention type: Drug
intervention name: BR9006-2
description: Administration to the M group: 50 mg of BR9006-2 will be administered one tablet once a day, eleven-day repeated-dose
Administration to the T+M group: 50 mg of BR9006-2 will be administered one tablet once a day, five-day repeated-dose
arm group label: Sequence T/M/T+M
other name: Mirabegron
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: An-Hye Kim
role: Principal Investigator
affiliation: CHA University
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Tamsulosin
mesh term: Mirabegron