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NCT00443625 Clinical Trial

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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00443625
Other study ID # SK3530_FE
Secondary ID
Status Completed
Phase Phase 1
First received February 22, 2007
Last updated April 16, 2013
Start date December 2006
Est. completion date February 2007

Study information
Verified date April 2013
Source SK Chemicals Co.,Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria:

- ages 19 to 50

- body weight of (IBM) ± 20%

Exclusion Criteria:

- cardiovascular disease

- color-blindness or weakness

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SK3530

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
SK Chemicals Co.,Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary PK parameters - AUC, Cmax, Tmax
Secondary PK parameters-t1/2
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