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
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 |
This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics (PKs) and safety.
Status | Completed |
Enrollment | 18 |
Est. completion date | May 2007 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
SK Chemicals Co.,Ltd. |
Korea, Republic of,
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 |
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