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Phase 1 Study of SK3530 to Investigate of the Effect of Food

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SK3530
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring SK3530, Food effect, Pharmacokinetics

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ages 19 to 50
  • body weight of (IBM) ± 20%

Exclusion Criteria:

  • cardiovascular disease
  • color-blindness or weakness

Sites / Locations

    Outcomes

    Primary Outcome Measures

    PK parameters - AUC, Cmax, Tmax

    Secondary Outcome Measures

    PK parameters-t1/2

    Full Information

    First Posted
    February 22, 2007
    Last Updated
    April 16, 2013
    Sponsor
    SK Chemicals Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00443625
    Brief Title
    Phase 1 Study of SK3530 to Investigate of the Effect of Food
    Official Title
    Clinical Trials to Investigate the Influence of Food on Pharmacokinetics of SK3530 in Healthy Male Volunteers.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    February 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SK Chemicals Co., Ltd.

    4. Oversight

    5. Study Description

    Brief Summary
    This study was designed to investigate the food effect of SK3530 on the pharmacokinetics (PKs).
    Detailed Description
    The PDE5 inhibitor, SK3530, is expected to be taken concomitantly with food. The food interaction studies of other PDE5 inhibitors (Viagra, Levitra and cialis) have already accomplished and the results have provided useful information to the patients. The objective of this study is to compare the pharmacokinetics (PKs) of SK3530 and its metabolite (SK3541) under the fasted and fed (low-fat meal and high-fat meal) conditions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erectile Dysfunction
    Keywords
    SK3530, Food effect, Pharmacokinetics

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    SK3530
    Primary Outcome Measure Information:
    Title
    PK parameters - AUC, Cmax, Tmax
    Secondary Outcome Measure Information:
    Title
    PK parameters-t1/2

    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: ages 19 to 50 body weight of (IBM) ± 20% Exclusion Criteria: cardiovascular disease color-blindness or weakness
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    In-Jin Jang, MD
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Phase 1 Study of SK3530 to Investigate of the Effect of Food

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