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Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HIP1503
HGP1103
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy male volunteers, age 19 to 45 years.
  2. The result of Body Mass Index(BMI) 17.5 kg/m2~ 30.5 kg/m2, body weight over 55kg.
  3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing.

Exclusion Criteria:

  1. Presence of medical history or a concurrent disease, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
  2. Medical history of Gastrointestinal Diseases that effects drug absorption (esophageal disease, chronic disease) or surgery( except appendectomy , herniolaparotomy)
  3. sit SBP > 140 mmHg, sit DBP > 90 mmHg
  4. Alcohol or Drug abuse within 1 year

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    sequence 1

    Sequence 2

    Arm Description

    HGP1103→HIP1503

    HIP1503→HGP1103

    Outcomes

    Primary Outcome Measures

    AUClast
    Solifenacin Cmax

    Secondary Outcome Measures

    Solifenacin AUCinf
    Solifenacin Tmax
    Solifenacin t1/2

    Full Information

    First Posted
    October 19, 2016
    Last Updated
    October 19, 2016
    Sponsor
    Hanmi Pharmaceutical Company Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02940314
    Brief Title
    Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers
    Official Title
    A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hanmi Pharmaceutical Company Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the safety and pharmacokinetic characteristics after administration of HIP1503 and HGP1103 in healthy male volunteers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overactive Bladder

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    sequence 1
    Arm Type
    Experimental
    Arm Description
    HGP1103→HIP1503
    Arm Title
    Sequence 2
    Arm Type
    Experimental
    Arm Description
    HIP1503→HGP1103
    Intervention Type
    Drug
    Intervention Name(s)
    HIP1503
    Other Intervention Name(s)
    Solifenacin tartrate 10.66 mg
    Intervention Type
    Drug
    Intervention Name(s)
    HGP1103
    Other Intervention Name(s)
    Solifenacin succinate 10 mg
    Primary Outcome Measure Information:
    Title
    AUClast
    Time Frame
    0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)
    Title
    Solifenacin Cmax
    Time Frame
    0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)
    Secondary Outcome Measure Information:
    Title
    Solifenacin AUCinf
    Time Frame
    0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)
    Title
    Solifenacin Tmax
    Time Frame
    0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)
    Title
    Solifenacin t1/2
    Time Frame
    0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)

    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: Healthy male volunteers, age 19 to 45 years. The result of Body Mass Index(BMI) 17.5 kg/m2~ 30.5 kg/m2, body weight over 55kg. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing. Exclusion Criteria: Presence of medical history or a concurrent disease, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. Medical history of Gastrointestinal Diseases that effects drug absorption (esophageal disease, chronic disease) or surgery( except appendectomy , herniolaparotomy) sit SBP > 140 mmHg, sit DBP > 90 mmHg Alcohol or Drug abuse within 1 year

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers

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