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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
  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 1

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:

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 May 22, 2013