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

2014-08-27 03:39:49 | BioPortfolio

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.

Study Design

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

Conditions

Erectile Dysfunction

Intervention

SK3530

Status

Active, not recruiting

Source

SK Chemicals Co.,Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:49-0400

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Medical and Biotech [MESH] Definitions

The inability in the male to have a PENILE ERECTION due to psychological or organ dysfunction.

Inability to achieve and maintain an erection (ERECTILE DYSFUNCTION) due to defects in the arterial blood flow to the PENIS, defect in venous occlusive function allowing blood drainage (leakage) from the erectile tissue (corpus cavernosum penis), or both.

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