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A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

Primary Purpose

Hypertension, Hyperlipidemia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Fimasartan/Amlodipine combination drug, Rosuvastatin
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Hyperlipidemia

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male subject, aged 19- 50 years

Exclusion Criteria:

  • History of clinically significant hypersensitivity to study drug, any other drug
  • Hypotension or hypertension
  • Active liver disease
  • History of gastrointestinal disease
  • History of excessive alcohol abuse
  • Participation in any other study within 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin

    Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin

    Outcomes

    Primary Outcome Measures

    Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin
    AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin

    Secondary Outcome Measures

    Full Information

    First Posted
    December 1, 2016
    Last Updated
    August 9, 2017
    Sponsor
    Boryung Pharmaceutical Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02995720
    Brief Title
    A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
    Official Title
    An Open-label, Randomized, Single-dose, 2X3X3 Partial Replicate, Crossover Study to Compare the Pharmacokinetics and Safety Between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 26, 2016 (Actual)
    Primary Completion Date
    November 10, 2016 (Actual)
    Study Completion Date
    May 30, 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    Fimasartan/Amlodipine combination drug, Rosuvastatin
    Primary Outcome Measure Information:
    Title
    Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin
    Time Frame
    0~72 hour after medication
    Title
    AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin
    Time Frame
    0~72 hour after medication

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male subject, aged 19- 50 years Exclusion Criteria: History of clinically significant hypersensitivity to study drug, any other drug Hypotension or hypertension Active liver disease History of gastrointestinal disease History of excessive alcohol abuse Participation in any other study within 3 months

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

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