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

NCT00853320 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-10-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Herbert Neuman, MD · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2003-02-28
Completion
2003-02-28

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 NCT00853320 on ClinicalTrials.gov