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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014