Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-20 @ 8:09 PM
Study NCT ID:
NCT00864357
Status:
COMPLETED
Last Update Posted:
2010-08-17
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Non-fasting Conditions
Sponsor:
Actavis Inc.
Organization:
Study Overview
Official Title:
A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg 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:
To compare the relative bioavailability of oxycodone HCl 5 mg / ibuprofen 400 mg tablets (Actavis Elizabeth LLC, Lot No. PI-1565) with that of COMBONOX® tablets (Forest Pharmaceuticals, Inc., Lot No. 010550) in healthy adult volunteers under non-fasting conditions.
Detailed Description:
Study Type: Interventional Study Design: Single dose randomized, two-period, two-treatment, two-sequence crossover study under non-fasting conditions comparing equal doses of the test and reference products.
Official Title: A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Non-Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Official Title: A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Non-Fasting Conditions
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?: