Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-02 @ 8:57 AM
Study NCT ID:
NCT00648856
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2008-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg
Sponsor:
Mylan Pharmaceuticals Inc
Organization:
Study Overview
Official Title:
Single-Dose Food In Vivo Bioequivalence Study of Sertraline Hydrochloride Tablets (100 mg; Mylan) and Zoloft® Tablets (100 mg; Pfizer) in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fed conditions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: