Erectile Dysfunction
Conditions
Keywords
SK3530, tamsulosin, hemodynamic interaction, safety
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.
Interventions
DRUGSK3530
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal decrease from baseline in supine SBP | within 6 hrs after SK3530 or placebo |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of postural hypotension | within 6 hrs after SK3530 or placebo |
| Maximal decrease from baseline in standing SBP, supine/standing DBP & HR | within 6 hrs after SK3530 or placebo |
| Outlier analysis: i) Standing/supine SBP < 85 mmHg, DBP < 45 mmHg; ii) Change in standing/supine SBP > 30 mmHg, DBP > 20 mmHg | within 6 hrs after SK3530 or placebo |
Countries
South Korea
Outcome results
None listed