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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.

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Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...

Erectile Dysfunction
Erectile dysfunction (ED or impotence) is the inability to get and maintain an erection that is sufficient for satisfactory sexual intercourse, and affects half of all men between the ages of 40 to 70. The causes of ED can be both physical and psycholo...


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