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
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring SK3530, Food effect, Pharmacokinetics
Eligibility Criteria
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
NCT ID
NCT00443625
First Posted
February 22, 2007
Last Updated
April 16, 2013
Sponsor
SK Chemicals Co., Ltd.
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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