Phase I Study to Investigate the Alcohol Interaction of SK3530
Phase 1
Completed
- Conditions
- Erectile Dysfunction
- Registration Number
- NCT00489450
- Lead Sponsor
- SK Chemicals Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method PK parameters - AUC, Cmax 24hr after administration
- Secondary Outcome Measures
Name Time Method Safety (Vital signs, Adverse events) until post-study visit
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of