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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489606
• Other study ID #: SK3530_DI_TS
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2007
• Last updated: June 20, 2007
• Start date: April 2007
• Est. completion date: June 2007

Study information

• Verified date: June 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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 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

• hypotension, hypertension, orthostatic hypertension

• abmormal QTc (>430 ms)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, 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	Maximal decrease from baseline in supine SBP		within 6 hrs after SK3530 or placebo
Secondary	Maximal decrease from baseline in standing SBP, supine/standing DBP & HR		within 6 hrs after SK3530 or placebo
Secondary	Outlier analysis: i) Standing/supine SBP < 85 mmHg, DBP < 45 mmHg; ii) Change in standing/supine SBP > 30 mmHg, DBP > 20 mmHg		within 6 hrs after SK3530 or placebo
Secondary	Incidence of postural hypotension		within 6 hrs after SK3530 or placebo