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

This study has been completed.

Sponsor:

Information provided by:

SK Chemicals Co.,Ltd.

ClinicalTrials.gov Identifier:

NCT00489606

First received: June 20, 2007

Last updated: NA

Last verified: June 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 20, 2007

Last Updated Date

June 20, 2007

Start Date ^ICMJE

April 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Erectile Dysfunction

Intervention ^ICMJE

Drug: SK3530

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Male

Ages

20 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00489606

Other Study ID Numbers ^ICMJE

SK3530_DI_TS

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

SK Chemicals Co.,Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

In-Jin Chang, MD

Seoul National University Hospital

Information Provided By

SK Chemicals Co.,Ltd.

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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