Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT00647894
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2008-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fasting Study of Alprazolam Extended-Release Tablets 1 mg to Xanax XR Tablets 1 mg
Sponsor:
Mylan Pharmaceuticals Inc
Organization:
Study Overview
Official Title:
Single-Dose Fasting In Vivo Bioequivalence Study of Alprazolam Extended-Release Tablets (1 mg; Mylan) to Xanax XR Tablets (1 mg; Pharmacia & Upjohn) 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 alprazolam 1 mg Extended-release tablets to Pharmacia \& Upjohn's Xanax XR 1 mg tablets following a single, oral 3 mg (3 x 1 mg) dose administered under fasting 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?: