Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530 - Full Text View

Sponsor:	SK Chemicals Co.,Ltd.
Information provided by:	SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00489606

Purpose

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

Condition	Intervention	Phase
Erectile Dysfunction	Drug: SK3530	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions Erectile Dysfunction

Drug Information available for: Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	16
Study Start Date:	April 2007
Study Completion Date:	June 2007

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.

Eligibility

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

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489606

Locations

Korea, Republic of
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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00489606 History of Changes
Other Study ID Numbers:	SK3530_DI_TS
Study First Received:	June 20, 2007
Last Updated:	June 20, 2007
Health Authority:	Korea: Food and Drug Administration

Keywords provided by SK Chemicals Co.,Ltd.:

SK3530
tamsulosin
hemodynamic interaction
safety

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists

Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012