Ignite Creation Date:
2024-05-05 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00751699
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2008-09-11
Brief Title:
Pharmacokinetics of Asacol 24 gDay and Lialda 24 gDay in Healthy Volunteers
Sponsor:
Warner Chilcott
Organization:
Warner Chilcott
Study Overview
Official Title:
A Randomized Open-label Multiple Dose Parallel Group Study to Evaluate 5 ASA and N Ac 5 ASA Pharmacokinetics Following Administration of Oral Doses of Asacol 24 gDay and Lialda 24 gDay for 7 Days in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2013-04
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 study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3 regimens of oral mesalamine 24 gday Lialda 24 gday 2 x 12 g every 24 hours Asacol 6 x 400 mg every 24 hours or Asacol 2 x 400 mg every 8 hours Primary endpoints were 5-ASA area under the plasma concentration versus time curve from zero to 24 hours AUC24 and total 5-ASA percent of dose excreted Ae over the 24-hour period on Day 7
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