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NCT01101178 · ClinicalTrials.gov registry record · Phase 1

To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

A Phase 1 study of Healthy, sponsored by Purdue Pharma.

Completed
Registry status
Phase 1
Development phase
79
Enrollment target
1
Study location

NCT01101178 is a Phase 1 study of Healthy that has completed, run by Purdue Pharma. The registered enrollment target is 79 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01101178, a Phase 1 study of Healthy, has completed, sponsored by Purdue Pharma.

COMPLETED
Registry status
Phase 1
Development phase
79 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.

Conditions Studied

Healthy

Interventions

  • DRUG Reformulated OXY (oxycodone HCl)
  • DRUG Original OxyContin® (OXY) (oxycodone HCl)

Study Locations (1)

Wisconsin

  • Covance Clinical Research Unit Madison - Madison

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2007-08
Est. Completion 2007-11
Phase Phase 1

Sponsor

Purdue Pharma

54 total trials

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What the Registry Record Tells You About NCT01101178

The ClinicalTrials.gov registry entry for NCT01101178 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower). The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Reformulated OXY (oxycodone HCl) is the first listed.

NCT01101178 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT01101178 about?

NCT01101178 is a clinical study titled "To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets". The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.

What is the current status of trial NCT01101178?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2007-08. Estimated completion is 2007-11.

What conditions does trial NCT01101178 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT01101178?

The interventions under investigation include: Reformulated OXY (oxycodone HCl) (DRUG), Original OxyContin® (OXY) (oxycodone HCl) (DRUG).

Who is sponsoring clinical trial NCT01101178?

This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01101178 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.