Phase 1 Study of SK3530 to Investigate of the Effect of Food

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

Completed

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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

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

The PDE5 inhibitor, SK3530, is expected to be taken concomitantly with food. The food interaction studies of other PDE5 inhibitors (Viagra, Levitra and cialis) have already accomplished and the results have provided useful information to the patients. The objective of this study is to compare the pharmacokinetics (PKs) of SK3530 and its metabolite (SK3541) under the fasted and fed (low-fat meal and high-fat meal) conditions.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

ages 19 to 50
body weight of (IBM) ± 20%

Exclusion criteria

cardiovascular disease
color-blindness or weakness

Treatment and study plan

SK3530

Drug

Primary outcomes

PK parameters - AUC, Cmax, Tmax

Secondary outcomes

PK parameters-t1/2

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

Clinical Trials to Investigate the Influence of Food on Pharmacokinetics of SK3530 in Healthy Male Volunteers.

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Mar 6, 2007
Registry last updated: Apr 18, 2013

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.

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

Completed