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

• Sponsor: SK Chemicals Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00443625
• Collaborator: (none)
• Enrollment: 15
• Duration (Months): 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: SK3530	Phase 1

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Trials to Investigate the Influence of Food on Pharmacokinetics of SK3530 in Healthy Male Volunteers.
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Feb 1, 2007
• Actual Study Completion Date: Feb 1, 2007

Outcome Measures

Primary Outcome Measures

1. PK parameters - AUC, Cmax, Tmax []

Secondary Outcome Measures

1. PK parameters-t1/2 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• ages 19 to 50

• body weight of (IBM) ± 20%

Exclusion Criteria:

• cardiovascular disease

• color-blindness or weakness

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• SK Chemicals Co., Ltd.

Investigators

• Principal Investigator: In-Jin Jang, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SK Chemicals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT00443625
• Other Study ID Numbers: SK3530_FE
• First Posted: Mar 6, 2007
• Last Update Posted: Apr 18, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by SK Chemicals Co., Ltd.: SK3530; Food effect; Pharmacokinetics
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

No Results Posted as of Apr 18, 2013