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

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction

Treatments: Drug: SK3530

Study type: Interventional

Funder types: Industry

Identifiers

NCT00489606

SK3530_DI_TS

Details and patient eligibility

About

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

Full description

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.

Enrollment: 16 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind