Phase 1 Study of SK3530 to Investigate of the Effect of Food
April 16, 2013 updated by: SK Chemicals Co., Ltd.
Clinical Trials to Investigate the Influence of Food on Pharmacokinetics of SK3530 in Healthy Male Volunteers.
This study was designed to investigate the food effect of SK3530 on the pharmacokinetics (PKs).
Study Overview
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 Type
Interventional
Enrollment
15
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- ages 19 to 50
- body weight of (IBM) ± 20%
Exclusion Criteria:
- cardiovascular disease
- color-blindness or weakness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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PK parameters - AUC, Cmax, Tmax
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Secondary Outcome Measures
Outcome Measure |
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PK parameters-t1/2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
February 22, 2007
First Submitted That Met QC Criteria
March 5, 2007
First Posted (Estimate)
March 6, 2007
Study Record Updates
Last Update Posted (Estimate)
April 18, 2013
Last Update Submitted That Met QC Criteria
April 16, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SK3530_FE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.