Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-01 @ 8:03 AM
Study NCT ID:
NCT00749359
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2008-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAXIL CR Bioequivalence Study
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
An Open-label, Randomized, Single Dose, Two-period Crossover Study to Demonstrate Bioequivalence Between the Controlled Release Paroxetine Tablet (37.5 mg) Manufactured at Cidra and Mississauga
Status:
COMPLETED
Status Verified Date:
2017-08
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 is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: