Phase I Study to Investigate the Alcohol Interaction of SK3530

Erectile Dysfunction Clinical Trial

Official title:

Clinical Trial to Investigate the Influence of Alcohol on the Pharmacokinetics and Safety of SK3530 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489450
• Other study ID #: SK3530_AI_2006
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2007
• Last updated: June 20, 2007
• Start date: March 2007
• Est. completion date: May 2007

Study information

• Verified date: March 2007
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• SK3530

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters - AUC, Cmax		24hr after administration
Secondary	Safety (Vital signs, Adverse events)		until post-study visit