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Phase I Study to Investigate the Alcohol Interaction of SK3530

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00489450
First Posted: June 21, 2007
Last Update Posted: June 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
SK Chemicals Co.,Ltd.
  Purpose
This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics (PKs) and safety.

Condition Intervention Phase
Erectile Dysfunction Drug: SK3530 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:
  • PK parameters - AUC, Cmax [ Time Frame: 24hr after administration ]

Secondary Outcome Measures:
  • Safety (Vital signs, Adverse events) [ Time Frame: until post-study visit ]

Enrollment: 18
Study Start Date: March 2007
Study Completion Date: May 2007
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.
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489450


Locations
Korea, Republic of
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
  More Information

ClinicalTrials.gov Identifier: NCT00489450     History of Changes
Other Study ID Numbers: SK3530_AI_2006
First Submitted: June 20, 2007
First Posted: June 21, 2007
Last Update Posted: June 21, 2007
Last Verified: March 2007

Keywords provided by SK Chemicals Co.,Ltd.:
SK3530
alcohol
pharmacokinetics
safety

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs