Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 12:34 AM
Study NCT ID:
NCT01570894
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2012-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
Sponsor:
Roxane Laboratories
Organization:
Study Overview
Official Title:
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2018-01
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:
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fed conditions.
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?: