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

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: SK3530

Primary Measures

• Maximal decrease from baseline in supine SBP
  • Time Frame: within 6 hrs after SK3530 or placebo
    

Secondary Measures

• Maximal decrease from baseline in standing SBP, supine/standing DBP & HR
  • Time Frame: within 6 hrs after SK3530 or placebo
    
• Outlier analysis: i) Standing/supine SBP < 85 mmHg, DBP < 45 mmHg; ii) Change in standing/supine SBP > 30 mmHg, DBP > 20 mmHg
  • Time Frame: within 6 hrs after SK3530 or placebo
    
• Incidence of postural hypotension
  • Time Frame: within 6 hrs 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)

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: SK Chemicals Co.,Ltd. Industry

Overall Clinical Trial Officials and Contacts

In-Jin Chang, MD Principal Investigator Seoul National University Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00489606

Study ID Number: SK3530_DI_TS

ClinicalTrials.gov Identifier: NCT00489606

Health Authority: Korea: Food and Drug Administration