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

June 20, 2007
June 20, 2007
April 2007
Not Provided
Maximal decrease from baseline in supine SBP [ Time Frame: within 6 hrs after SK3530 or placebo ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530
Clinical Trial to Investigate the Influence of Drug Interaction After Oral Administration of Tamsulosin and SK3530 in Healthy Male Volunteers

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Erectile Dysfunction
Drug: SK3530
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2007
Not Provided

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)
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00489606
SK3530_DI_TS
Yes
Not Provided
SK Chemicals Co.,Ltd.
Not Provided
Principal Investigator: In-Jin Chang, MD Seoul National University Hospital
SK Chemicals Co.,Ltd.
June 2007

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