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Phase I Study to Investigate the Alcohol Interaction of SK3530

This study has been completed.
Sponsor:
Information provided by:
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00489450
First received: June 20, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00489450     History of Changes
Other Study ID Numbers: SK3530_AI_2006
Study First Received: June 20, 2007
Last Updated: June 20, 2007
Health Authority: Korea: Food and Drug Administration

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
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013