Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-25 @ 4:12 PM
Study NCT ID:
NCT01188057
Status:
COMPLETED
Last Update Posted:
2010-08-25
First Post:
2010-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Non-Fasting Conditions
Sponsor:
Actavis Inc.
Organization:
Study Overview
Official Title:
A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets Under Non-fasting Conditions
Status:
COMPLETED
Status Verified Date:
2010-08
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 compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2 mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult volunteers administered under non-fasting conditions.
Detailed Description:
Study Type: Interventional Study Design: This was a single-center, randomized, two-way crossover study conducted under non-fasting conditions Official Title: A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets under Non-Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
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?: