Back to resultsPhase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and 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, tamsulosin, hemodynamic interaction, safety
Eligibility Criteria
Inclusion Criteria:
- ages 20 to 50
- body weight of IBM±20%
Exclusion Criteria:
- cardiovascular disease
- color-blindness or weakness
- hypotension, hypertension, orthostatic hypertension
- abmormal QTc (>430 ms)
Sites / Locations
- Seoul National University Hospital
Outcomes
Primary Outcome Measures
Maximal decrease from baseline in supine SBP
Secondary Outcome Measures
Maximal decrease from baseline in standing SBP, supine/standing DBP & HR
Outlier analysis: i) Standing/supine SBP < 85 mmHg, DBP < 45 mmHg; ii) Change in standing/supine SBP > 30 mmHg, DBP > 20 mmHg
Incidence of postural hypotension
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00489606
Brief Title
Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530
Official Title
Clinical Trial to Investigate the Influence of Drug Interaction After Oral Administration of Tamsulosin and SK3530 in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and tamsulosin, phase I study in healthy volunteers was designed.
Detailed Description
During each of the two periods of a randomized, double-blind, placebo-controlled, crossover study, 16 healthy men received tamsulosin 0.2 mg daily for 7 days and either a single 100 mg of SK3530 or placebo on day7. The blood pressure and heart rate were monitored before and for 24 hours after SK3530 or placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
SK3530, tamsulosin, hemodynamic interaction, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SK3530
Primary Outcome Measure Information:
Title
Maximal decrease from baseline in supine SBP
Time Frame
within 6 hrs after SK3530 or placebo
Secondary Outcome Measure Information:
Title
Maximal decrease from baseline in standing SBP, supine/standing DBP & HR
Time Frame
within 6 hrs after SK3530 or placebo
Title
Outlier analysis: i) Standing/supine SBP < 85 mmHg, DBP < 45 mmHg; ii) Change in standing/supine SBP > 30 mmHg, DBP > 20 mmHg
Time Frame
within 6 hrs after SK3530 or placebo
Title
Incidence of postural hypotension
Time Frame
within 6 hrs after SK3530 or placebo
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
hypotension, hypertension, orthostatic hypertension
abmormal QTc (>430 ms)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Jin Chang, 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 Drug Interaction After Oral Administration of Tamsulosin and SK3530
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