Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT03327558
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2017-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
Sponsor:
Bausch Health Americas, Inc.
Organization:
Study Overview
Official Title:
Full-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate and compare the bioavailability of mesalamine
Detailed Description:
The objective of this study is to evaluate and compare the bioavailability of mesalamine and therefore to assess the bioequivalence of 375 mg APRISOTM extended-release capsule manufactured at a new site versus the approved 375 mg APRISOTM extended-release capsule after a single oral dose administration under fasting conditions.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: