Erectile Dysfunction
Conditions
Keywords
SK3530, alcohol, pharmacokinetics, safety
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.
Interventions
DRUGSK3530
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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 * no availability to intake 0.5 g/Kg alcohol * abnormal supine blood preesure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters - AUC, Cmax | 24hr after administration |
Secondary
| Measure | Time frame |
|---|---|
| Safety (Vital signs, Adverse events) | until post-study visit |
Countries
South Korea
Outcome results
None listed