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To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities

2014-08-27 03:14:39 | BioPortfolio

Summary

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted state.

Description

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Reformulated OXY (Totowa) (oxycodone HCl), Reformulated OXY (Wilson) (oxycodone HCl)

Location

Covance Clinical Research Unit Honolulu
Honolulu
Hawaii
United States
96813

Status

Completed

Source

Purdue Pharma LP

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:39-0400

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