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

NCT ID: NCT00443625

Last Updated: 2013-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2007-02-28

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

SK3530

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• cardiovascular disease
• color-blindness or weakness

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

In-Jin Jang, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Other Identifiers

SK3530_FE

Identifier Type: -

Identifier Source: org_study_id