Evidence map›Paper›PMID 31065992›Full record

Trial reportAdvances in therapy2019

Relative Oral Bioavailability of an Abuse-Deterrent, Immediate-Release Formulation of Oxycodone, Oxycodone ARIR in a Randomized Study.

Lynn R Webster, Eric R Kinzler, Carmela Pantaleon, Matthew Iverson, Stefan Aigner

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Lynn R WebsterPRA Health Sciences, Salt Lake City, UT, USA. lrwebstermd@gmail.com.ORCID http://orcid.org/0000-0001-8609-9424
Eric R KinzlerInspirion Delivery Sciences LLC, Morristown, NJ, USA.
Carmela PantaleonInspirion Delivery Sciences LLC, Morristown, NJ, USA.
Matthew IversonInspirion Delivery Sciences LLC, Morristown, NJ, USA.
Stefan AignerInspirion Delivery Sciences LLC, Morristown, NJ, USA.
PRA Health Sciences · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOxycodone ARIR is a novel oral, abuse-deterrent, immediate-release (IR) formulation with physical and chemical properties that deter misuse and abuse by non-oral routes. In this single-dose pharmacokinetic study, we assessed the relative bioavailability of oxycodone for Oxycodone ARIR and IR oxycodone, and the effect of food on Oxycodone ARIR following oral administration.

methodsThis open-label, randomized study in healthy adults compared the relative bioavailability of Oxycodone ARIR 30 mg to IR oxycodone 30 mg under fasted conditions, and Oxycodone ARIR under fed versus fasted conditions. Pharmacokinetic parameters included area under the concentration-time curve from time 0 to the last measured concentration (AUC

resultsFifty-eight subjects completed the study. Under fasted conditions, AUC

conclusionIn this single-dose pharmacokinetic evaluation, fasted Oxycodone ARIR 30 mg had similar bioavailability to and is expected to have the same efficacy and safety profile as IR oxycodone. When administered in the fed state, pharmacokinetic parameters were slightly higher; however, these differences were considered not clinically meaningful and show that Oxycodone ARIR can be administered with or without food.

fundingThis study was funded by Inspirion Delivery Sciences, LLC. Daiichi Sankyo, Inc. funded the journal's article processing charges and open access fee. Plain language summary available for this article.

Indexed as

Administration, OralAdultAnalgesics, OpioidArea Under CurveBiological AvailabilityCross-Over StudiesDose-Response Relationship, DrugFastingFemaleHeadacheHumansMaleNauseaOxycodoneYoung AdultAnalgesics, OpioidOxycodoneAbuse-deterrent formulationBioequivalenceImmediate-releaseOpioidsOxycodonePainPharmacokinetics

Identifiers

PMID31065992
PMCPMC6824394
OpenAlexW2944329429

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.