Erectile DysfunctionPhase 1NCT00489606
Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530
A Phase 1 study testing SK3530 in people with Erectile Dysfunction, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and tamsulosin, phase I study in healthy volunteers was designed. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- SK3530
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2007to Jun 2007
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 20 to 50
- body weight of IBM±20%
Who cannot join
- cardiovascular disease
- color-blindness or weakness
- hypotension, hypertension, orthostatic hypertension
- abmormal QTc (>430 ms)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- SK3530
- Keywords
- SK3530, tamsulosin, hemodynamic interaction, safety
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK3530Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal decrease from baseline in supine SBP
Measured: within 6 hrs after SK3530 or placebo
Secondary outcomes (3)
Maximal decrease from baseline in standing SBP, supine/standing DBP & HR
Measured: 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
Measured: within 6 hrs after SK3530 or placebo
Incidence of postural hypotension
Measured: within 6 hrs after SK3530 or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startApr 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- In-Jin Chang, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489606
- Sponsor's protocol ID
- SK3530_DI_TS
- Status last verified
- Jun 2007
- First submitted
- 20 Jun 2007
- Last updated
- 21 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes