Mallinkrodt isnt so bad afterall
http://www.bioportfolio.com/resourc...oride-30-Mg-Tablets-And-Roxicodone-30-Mg.html
I FOUND THIS ARTICLE FINALLY AFTER LOOKING AROUND FOR SOMETHING ELSE IT COMPARES NAME BRAND ROXI TO MALLIE GENERIC 30MG IR PILLS, ITS A GOOD READ.......ENJOY!!!
Fed Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
Summary
The objective of this open-label, randomized, two-period crossover study was to compare the
oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an
equivalent oral dose of a commercially available oxycodone tablet (Roxicodone� 30 mg, Roxane
Laboratories, Inc.) in a test group of healthy subjects under fed conditions.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Roxicodone� tablet 30 mg, Oxycodone hydrochloride tablet 30 mg
Status
Completed
Source
Mallinckrodt
Results (where available)
View Results
Links
View Results
* Source
* Information obtained from ClinicalTrials.gov on July 15, 2010
Fed Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
This study has been completed.
First Received: February 26, 2009 Last Updated: February 27, 2009 History of Changes
Sponsor: Mallinckrodt
Information provided by: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00853736
Purpose
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 30 mg, Roxane Laboratories, Inc.) in a test group of healthy subjects under fed conditions.
Condition Intervention Phase
Healthy
Drug: Roxicodone™ tablet 30 mg
Drug: Oxycodone hydrochloride tablet 30 mg
Phase I
Study Type: Interventional
Study Design: Allocation: Randomized
Control: Active Control
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of an Immediate Release Test Tablet Formulation of Oxycodone Hydrochloride (30 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Roxicodone™, 30 mg Tablet, Roxane Laboratories, Inc.) in Normal Human Subjects Under Fed Conditions
Resource links provided by NLM:
MedlinePlus related topics: Malnutrition
Drug Information available for: Oxycodone Oxycodone hydrochloride
U.S. FDA Resources
Further study details as provided by Mallinckrodt:
Primary Outcome Measures:
* Bioequivalence based on AUCt, AUCinf and Cmax [ Time Frame: Two-period crossover with blood samples obtained prior to and following each dose at selected times through 36 hours. Washout period between doses was 7 days. ] [ Designated as safety issue: No ]
Enrollment: 23
Study Start Date: February 2003
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Oxycodone hydrochloride tablet 30 mg
Drug: Oxycodone hydrochloride tablet 30 mg
Oxycodone hydrochloride tablet 30 mg, single dose with food
B: Active Comparator
Roxicodone™ tablet 30 mg
Drug: Roxicodone™ tablet 30 mg
Roxicodone™ tablet 30 mg, single dose with food