Back to resultsPhase I Study to Investigate the Alcohol Interaction of SK3530
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SK3530
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring SK3530, alcohol, pharmacokinetics, safety
Eligibility Criteria
Inclusion Criteria:
- ages 20 to 50
- body weight of IBM ± 20%
Exclusion Criteria:
- cardiovascular disease
- color-blindness or weakness
- no availability to intake 0.5 g/Kg alcohol
- abnormal supine blood preesure
Sites / Locations
- Seoul National University Hospital
Outcomes
Primary Outcome Measures
PK parameters - AUC, Cmax
Secondary Outcome Measures
Safety (Vital signs, Adverse events)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00489450
Brief Title
Phase I Study to Investigate the Alcohol Interaction of SK3530
Official Title
Clinical Trial to Investigate the Influence of Alcohol on the Pharmacokinetics and Safety of SK3530 in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics (PKs) and safety.
Detailed Description
This study was a randomized, open, single-dose, three-treatment, three-period, three-sequence, crossover study in which subjects were received, in random order, SK3530 100mg alone, 0.5g/Kg of alcohol alone, and SK3530 plus alcohol together. There was a minimum of a 7 day washout period between treatments. The alcohol was diluted to 240 mL with water. The contents were drunk in 1 minutes or less. For SK3530 and metabolite measurement, plasma samples were collected at pre-scheduled time and the safety was monitored all through the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
SK3530, alcohol, pharmacokinetics, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SK3530
Primary Outcome Measure Information:
Title
PK parameters - AUC, Cmax
Time Frame
24hr after administration
Secondary Outcome Measure Information:
Title
Safety (Vital signs, Adverse events)
Time Frame
until post-study visit
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ages 20 to 50
body weight of IBM ± 20%
Exclusion Criteria:
cardiovascular disease
color-blindness or weakness
no availability to intake 0.5 g/Kg alcohol
abnormal supine blood preesure
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase I Study to Investigate the Alcohol Interaction of SK3530
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