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

June 20, 2007 updated by: SK Chemicals Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal decrease from baseline in supine SBP
Time Frame: within 6 hrs after SK3530 or placebo
within 6 hrs after SK3530 or placebo

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximal decrease from baseline in standing SBP, supine/standing DBP & HR
Time Frame: within 6 hrs after SK3530 or placebo
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
Time Frame: within 6 hrs after SK3530 or placebo
within 6 hrs after SK3530 or placebo
Incidence of postural hypotension
Time Frame: within 6 hrs after SK3530 or placebo
within 6 hrs after SK3530 or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Chemicals Co., Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

June 21, 2007

Last Update Submitted That Met QC Criteria

June 20, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SK3530_DI_TS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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