Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318838
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2006-04-25
Brief Title:
Effect of Azimilide Dihydrochloride on Renal Function
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
A Double-blind Randomized Parallel-group Placebo-controlled Multiple-dose Study to Assess the Effect of 125 mgDay Orally Administered Azimilide Dihydrochloride on Renal Function and Hemodynamics in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2017-01
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:
This study will assess the effect of multiple dosing of 125 mg azimilide on glomerular filtration rate GFR and total creatinine clearance GFR active secretion in healthy subjects Also it will assess the effect of multiple dosing of 125 mg azimilide on renal hemodynamics RPF in healthy subjects
Detailed Description:
This is a double-blind parallel-group placebo-controlled multiple-dose single-site study in healthy male and female volunteers Oral azimilide 125 mg or placebo will be administered every 12 hours for 3 days followed by 125 mg every 24 hours for 3 days The study will include a total of 21 healthy subjects 14 active and 7 placebo all of whom will be confined at the study center for 9 nights
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