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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00443625

Enrollment

Registered

2007-03-06

Start date

2006-12-31

Completion date

2007-02-28

Last updated

2013-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

SK3530, Food effect, Pharmacokinetics

Brief summary

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

Detailed description

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.

Interventions

DRUGSK3530

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* cardiovascular disease * color-blindness or weakness

Design outcomes

Primary

Measure	Time frame
PK parameters - AUC, Cmax, Tmax	—

Secondary

Measure	Time frame
PK parameters-t1/2	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026