Phase I Study to Investigate the Alcohol Interaction of SK3530

Clinical Trial to Investigate the Influence of Alcohol on the Pharmacokinetics and Safety of SK3530 in Healthy Male Volunteers

This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics (PKs) and safety.

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.

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