Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530
Phase 1
Completed
- Conditions
- Erectile Dysfunction
- Registration Number
- NCT00489606
- Lead Sponsor
- SK Chemicals Co., Ltd.
- Brief Summary
To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and tamsulosin, phase I study in healthy volunteers was designed.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Maximal decrease from baseline in supine SBP within 6 hrs after SK3530 or placebo
- Secondary Outcome Measures
Name Time Method Maximal decrease from baseline in standing SBP, supine/standing DBP & HR 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 within 6 hrs after SK3530 or placebo Incidence of postural hypotension within 6 hrs after SK3530 or placebo
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of