Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489606
Status:
COMPLETED
Last Update Posted:
2007-06-21
First Post:
2007-06-20
Brief Title:
Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530
Sponsor:
SK Chemicals Co Ltd
Organization:
SK Chemicals Co Ltd
Study Overview
Official Title:
Clinical Trial to Investigate the Influence of Drug Interaction After Oral Administration of Tamsulosin and SK3530 in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the pharamcodynamic effects of coadministrated SK3530PDE5 inhibitor and tamsulosin phase I study in healthy volunteers was designed
Detailed Description:
During each of the two periods of a randomized double-blind placebo-controlled crossover study 16 healthy men received tamsulosin 02 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None