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

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction

Treatments: Drug: SK3530

Study type: Interventional

Funder types: Industry

Identifiers

NCT00443625

SK3530_FE

Details and patient eligibility

About

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

Full 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.

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• cardiovascular disease
• color-blindness or weakness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)