NCT00853320

Fasting Study of Oxycodone Hydrochloride 15 mg Tablets and Roxicodone™ 15 mg Tablets

An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of an Immediate Release Test Tablet Formulation of Oxycodone Hydrochloride (15 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Roxicodone™, 15 mg Tablet, Roxane Laboratories, Inc.) in Normal Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 15 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 15 mg, Roxane Laboratories, Inc.) in a test group of healthy subjects under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oxycodone hydrochloride tablet 15 mg	Oxycodone hydrochloride tablet 15 mg, single dose fasting
DRUG	Roxicodone™ tablet 15 mg	Roxicodone™ tablet 15 mg, single dose fasting

Timeline

• Start date: 2003-02-01
• Primary completion: 2003-02-01
• Completion: 2003-02-01
• First posted: 2009-03-02
• Last updated: 2016-10-19

Locations

1 site across 1 country: United States