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

Condition(s) targeted: Erectile Dysfunction

Intervention: SK3530 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: SK Chemicals Co.,Ltd.

Official(s) and/or principal investigator(s):
In-Jin Chang, MD, Principal Investigator, Affiliation: Seoul National University Hospital

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

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study

Primary outcome: Maximal decrease from baseline in supine SBP

Secondary outcome:

Maximal decrease from baseline in standing SBP, supine/standing DBP & HR

Outlier analysis: i) Standing/supine SBP < 85 mmHg, DBP < 45 mmHg; ii) Change in standing/supine SBP > 30 mmHg, DBP > 20 mmHg

Incidence of postural hypotension

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.

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

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)

Seoul National University Hospital, Seoul 110-744, Korea, Republic of

Starting date: April 2007
Ending date: June 2007
Last updated: June 20, 2007