Skip to main content
OpenTrials
Completed

NCT Number: NCT00489450

Phase I Study to Investigate the Alcohol Interaction of SK3530

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SK3530

Drug

Primary outcomes

  1. PK parameters - AUC, Cmax

    Time frame: 24hr after administration

Secondary outcomes

  1. Safety (Vital signs, Adverse events)

    Time frame: until post-study visit

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2007
First posted
Jun 21, 2007
Registry last updated
Jun 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.