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

• Sponsor: SK Chemicals Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00489606
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: SK3530	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Clinical Trial to Investigate the Influence of Drug Interaction After Oral Administration of Tamsulosin and SK3530 in Healthy Male Volunteers
• Study Start Date: Apr 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. Maximal decrease from baseline in supine SBP [within 6 hrs after SK3530 or placebo]

Secondary Outcome Measures

1. Maximal decrease from baseline in standing SBP, supine/standing DBP & HR [within 6 hrs after SK3530 or placebo]

2. 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]

3. Incidence of postural hypotension [within 6 hrs after SK3530 or placebo]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• SK Chemicals Co., Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00489606
• Other Study ID Numbers: SK3530_DI_TS
• First Posted: Jun 21, 2007
• Last Update Posted: Jun 21, 2007
• Last Verified: Jun 1, 2007

• Keywords provided by , ,: SK3530; tamsulosin; hemodynamic interaction; safety
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

No Results Posted as of Jun 21, 2007