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

SK Chemicals Co., Ltd.15 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction

Interventions

SK3530DRUG

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * ages 19 to 50 * body weight of (IBM) ± 20% Exclusion Criteria: * cardiovascular disease * color-blindness or weakness

Outcomes

Primary Outcomes

PK parameters - AUC, Cmax, Tmax

Secondary Outcomes

PK parameters-t1/2

Data from ClinicalTrials.gov

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