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Phase I Study to Investigate the Alcohol Interaction of SK3530

Sponsor
SK Chemicals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00489450
Collaborator
(none)
18
Enrollment
1
Location
2
Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This study was a randomized, open, single-dose, three-treatment, three-period, three-sequence, crossover study in which subjects were received, in random order, SK3530 100mg alone, 0.5g/Kg of alcohol alone, and SK3530 plus alcohol together. There was a minimum of a 7 day washout period between treatments. The alcohol was diluted to 240 mL with water. The contents were drunk in 1 minutes or less. For SK3530 and metabolite measurement, plasma samples were collected at pre-scheduled time and the safety was monitored all through the study.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Trial to Investigate the Influence of Alcohol on the Pharmacokinetics and Safety of SK3530 in Healthy Male Volunteers
Study Start Date :
Mar 1, 2007
Actual Study Completion Date :
May 1, 2007

Outcome Measures

Primary Outcome Measures

  1. PK parameters - AUC, Cmax [24hr after administration]

Secondary Outcome Measures

  1. Safety (Vital signs, Adverse events) [until post-study visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • ages 20 to 50

  • body weight of IBM ± 20%

Exclusion Criteria:

  • cardiovascular disease

  • color-blindness or weakness

  • no availability to intake 0.5 g/Kg alcohol

  • abnormal supine blood preesure

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 110-744

Sponsors and Collaborators

  • SK Chemicals Co., Ltd.

Investigators

  • Principal Investigator: In-Jin Jang, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00489450
Other Study ID Numbers:
  • SK3530_AI_2006
First Posted:
Jun 21, 2007
Last Update Posted:
Jun 21, 2007
Last Verified:
Mar 1, 2007
Keywords provided by , ,
SK3530
alcohol
pharmacokinetics
safety
Additional relevant MeSH terms:
Erectile Dysfunction

Study Results

No Results Posted as of Jun 21, 2007