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Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

Primary Purpose

Hypertension and Dyslipidemia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Telmisartan
Amlodipine
Rosuvastatin
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension and Dyslipidemia

Eligibility Criteria

19 Years - 49 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male who are ≥19, <50 years old
  • Man who weights over 55kg and whose BMI is 18~30(kg/m2)
  • Man who doesn't have any chronic disease or history of disease

Exclusion Criteria:

  • man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Reference1

    Reference2

    Arm Description

    single(Reference1) -> combination(Reference1+Reference2)

    single(Reference2) -> combination(Reference1+Reference2)

    Outcomes

    Primary Outcome Measures

    AUC of Reference 1
    Cmax of Reference 1
    AUC of Reference 2
    Cmax of Reference 2

    Secondary Outcome Measures

    Full Information

    First Posted
    October 12, 2016
    Last Updated
    October 12, 2016
    Sponsor
    Daewon Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02933658
    Brief Title
    Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension and Dyslipidemia

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Reference1
    Arm Type
    Experimental
    Arm Description
    single(Reference1) -> combination(Reference1+Reference2)
    Arm Title
    Reference2
    Arm Type
    Experimental
    Arm Description
    single(Reference2) -> combination(Reference1+Reference2)
    Intervention Type
    Drug
    Intervention Name(s)
    Telmisartan
    Intervention Type
    Drug
    Intervention Name(s)
    Amlodipine
    Intervention Type
    Drug
    Intervention Name(s)
    Rosuvastatin
    Primary Outcome Measure Information:
    Title
    AUC of Reference 1
    Time Frame
    0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
    Title
    Cmax of Reference 1
    Time Frame
    0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
    Title
    AUC of Reference 2
    Time Frame
    0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
    Title
    Cmax of Reference 2
    Time Frame
    0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male who are ≥19, <50 years old Man who weights over 55kg and whose BMI is 18~30(kg/m2) Man who doesn't have any chronic disease or history of disease Exclusion Criteria: man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

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