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

NCT00864526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-08-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher R. Longnecker,, M.D. · Cetero Research, San Antonio

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00864526 on ClinicalTrials.gov