NCT00489450

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	SK3530

Timeline

• Start date: 2007-03-01
• Completion: 2007-05-01
• First posted: 2007-06-21
• Last updated: 2007-06-21

Locations

1 site across 1 country: South Korea