Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-29 @ 3:53 AM
Study NCT ID:
NCT00853268
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2009-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fed Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets
Sponsor:
Mallinckrodt
Organization:
Study Overview
Official Title:
An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a Controlled-Release Test Tablet Formulation of Oxycodone Hydrochloride (40 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (OxyContin® 40 mg, Purdue Pharma L.P.) in Normal Human Subjects Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2016-09
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 open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral dose of a commercially available controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.) in a test group of healthy subjects 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?: