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

This study has been completed.
Information provided by:
SK Chemicals Co.,Ltd. Identifier:
First received: June 20, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

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:

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.


Ages Eligible for Study:   20 Years to 50 Years
Genders 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
Please refer to this study by its identifier: NCT00489606

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Principal Investigator: In-Jin Chang, MD Seoul National University Hospital
  More Information

No publications provided 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.:
hemodynamic interaction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
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 processed this record on April 17, 2014