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Clinical Trials/NCT00443625
NCT00443625CompletedPhase 1

Clinical Trials to Investigate the Influence of Food on Pharmacokinetics of SK3530 in Healthy Male Volunteers.

SK Chemicals Co., Ltd.0 sites15 target enrollmentStarted: December 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
15
Primary Endpoint
PK parameters - AUC, Cmax, Tmax
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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