Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530

Clinical Trial to Investigate the Influence of Drug Interaction After Oral Administration of Tamsulosin and SK3530 in Healthy Male Volunteers

To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and tamsulosin, phase I study in healthy volunteers was designed.

During each of the two periods of a randomized, double-blind, placebo-controlled, crossover study, 16 healthy men received tamsulosin 0.2 mg daily for 7 days and either a single 100 mg of SK3530 or placebo on day7. The blood pressure and heart rate were monitored before and for 24 hours after SK3530 or placebo.

Inclusion Criteria:

• ages 20 to 50
• body weight of IBM±20%

Exclusion Criteria:

• cardiovascular disease
• color-blindness or weakness
• hypotension, hypertension, orthostatic hypertension
• abmormal QTc (>430 ms)