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The PK Study of the JLP-1207 and Solifenacin/Tamsulosin in Healthy Male Volunteers.

Primary Purpose

LUTS(Lower Urinary Tract Symptoms), Benign Prostatic Hyperplasia, Overactive Bladder

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
JLP-1207
Solifenacin 5mg+Tamsulosin 0.2mg
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for LUTS(Lower Urinary Tract Symptoms) focused on measuring α1-blockers, antimuscarinic agent

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 19~45 years healthy male
  • Body weight is over 55kg, BMI measurement 18.0kg/m^2~ 27.0kg/m^2
  • Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
  • Researchers determined suitable volunteers through physical examination, laboratory tests

Exclusion Criteria:

  • History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
  • Sitting SBP>150mmHg or <100mmHg, sitting DBP>100mmHg or <60mmHg, after 3 minutes break
  • An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
  • Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)
  • History of drug abuse
  • Positive urine drug screening
  • Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study.
  • Donated blood within 60 days prior to the first administration day in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    JLP-1207

    Solifenacin 5mg+Tamsulosin 0.2mg

    Arm Description

    JLP-1207 dosing in the fed state(high fat meal)

    Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal)

    Outcomes

    Primary Outcome Measures

    AUClast, Cmax

    Secondary Outcome Measures

    AUCinf
    Tmax
    t1/2
    CL/F
    Vd/f

    Full Information

    First Posted
    July 8, 2015
    Last Updated
    June 23, 2016
    Sponsor
    Jeil Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02494349
    Brief Title
    The PK Study of the JLP-1207 and Solifenacin/Tamsulosin in Healthy Male Volunteers.
    Official Title
    Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jeil Pharmaceutical Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin between Solifenacin and Tamsulosin in healthy male volunteers.
    Detailed Description
    A randomized, open-label, single dose, two-way crossover study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    LUTS(Lower Urinary Tract Symptoms), Benign Prostatic Hyperplasia, Overactive Bladder
    Keywords
    α1-blockers, antimuscarinic agent

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    JLP-1207
    Arm Type
    Experimental
    Arm Description
    JLP-1207 dosing in the fed state(high fat meal)
    Arm Title
    Solifenacin 5mg+Tamsulosin 0.2mg
    Arm Type
    Experimental
    Arm Description
    Solifenacin 5mg+Tamsulosin 0.2mg in the fed state(high fat meal)
    Intervention Type
    Drug
    Intervention Name(s)
    JLP-1207
    Intervention Description
    The subjects will receive JLP-1207 under fed(high fat meal) condition. After washout period, the subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition.
    Intervention Type
    Drug
    Intervention Name(s)
    Solifenacin 5mg+Tamsulosin 0.2mg
    Intervention Description
    The subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. After washout period, the subjects will receive JLP-1207 under fed(high fat meal) condition.
    Primary Outcome Measure Information:
    Title
    AUClast, Cmax
    Time Frame
    192 hours
    Secondary Outcome Measure Information:
    Title
    AUCinf
    Time Frame
    192 hours
    Title
    Tmax
    Time Frame
    192 hours
    Title
    t1/2
    Time Frame
    192 hours
    Title
    CL/F
    Time Frame
    192 hours
    Title
    Vd/f
    Time Frame
    192 hours

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 19~45 years healthy male Body weight is over 55kg, BMI measurement 18.0kg/m^2~ 27.0kg/m^2 Signed informed consent form from to participate voluntarily and to comply with the trial requirements. Researchers determined suitable volunteers through physical examination, laboratory tests Exclusion Criteria: History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.) Sitting SBP>150mmHg or <100mmHg, sitting DBP>100mmHg or <60mmHg, after 3 minutes break An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason. Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery) History of drug abuse Positive urine drug screening Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study. Donated blood within 60 days prior to the first administration day in this study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kyung-sang Yu, M.D., Ph.D.
    Organizational Affiliation
    Seoul National University Hospital(SNUH)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The PK Study of the JLP-1207 and Solifenacin/Tamsulosin in Healthy Male Volunteers.

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