Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413426
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2006-12-18
Brief Title:
Study to Compare How the Body Changes the Blood Level of Darifenacin Tablet Form vs the Modified Release Liquid Form in Healthy Subjects
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
An Open-labeled Randomized Single Dose Three Period 2-sequence Crossover Study to Investigate the Pharmacokinetics of Darifenacin When Given as 75 mg Oral Doses of a Modified Release Suspension as Compared to the Commercial Modified Release Tablet in Healthy Adult
Status:
COMPLETED
Status Verified Date:
2016-04
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 purpose of this study is to compare the how the body changes the blood level of a single dose of darifenacin when given as 75 mg modified release tablet and the modified release liquid suspension 15 mgml under fasted and fed conditions in healthy subjects
Detailed Description:
None
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