Phase I Study to Investigate the Alcohol Interaction of SK3530

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction

Treatments: Drug: SK3530

Study type: Interventional

Funder types: Industry

Identifiers

NCT00489450

SK3530_AI_2006

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)