NCT00864526

A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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 fasting conditions.

Detailed description

Study Type: Interventional Study Design: Single dose randomized, two-period, two-treatment, two-sequence crossover study under 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 Fasting Conditions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose	A: Experimental SSubjects received Actavis formulated products under fasting conditions
DRUG	COMBONOX® tablets, single dose	B: Active comparator Subjects received Forest Pharmaceuticals, Inc formulated products under fasting conditions

Timeline

• Start date: 2006-10-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2009-03-18
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States