Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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
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   (Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Identifier: NCT00489606     History of Changes
Other Study ID Numbers: SK3530_DI_TS
Study First Received: June 20, 2007
Last Updated: June 20, 2007

Keywords provided by SK Chemicals Co.,Ltd.:
hemodynamic interaction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on April 28, 2017