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Fed Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets

NCT00853268 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-09-09

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Controlled-Release Oxycodone Hydrochloride 40 mg

Controlled-Release Oxycodone Hydrochloride 40 mg, single dose with food

DRUG

OxyContin® 40 mg tablet

OxyContin® 40 mg tablet, single dose with food

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2005-04-30
Completion
2005-04-30

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 NCT00853268 on ClinicalTrials.gov