Evidence map›Paper›PMID 32748570›Full record

Trial reportClinical pharmacology in drug development2021

Safety, Tolerability, and Dose Proportionality of a Novel Transdermal Fentanyl Matrix Patch and Bioequivalence With a Matrix Fentanyl Patch: Two Phase 1 Single-Center Open-Label, Randomized Crossover Studies in Healthy Japanese Volunteers.

Ulrike Lorch, Tomasz Pierscionek, Anne Freier, Christopher S Spencer, Jörg Täubel

Open access · hybridAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology in drug development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact, top 92% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Article
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 2 institutions in 1 country.

Ulrike LorchRichmond Pharmacology Ltd., St George's University London, London, UK.
Tomasz PierscionekRichmond Pharmacology Ltd., St George's University London, London, UK.
Anne FreierRichmond Research Institute, London, UK.
Christopher S SpencerRichmond Research Institute, London, UK.
Jörg TäubelRichmond Pharmacology Ltd., St George's University London, London, UK.
St George's, University of London · GBRichmond School and Sixth Form College · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Two open-label, single-dose, randomized crossover studies were conducted in healthy Japanesemen to (1) assess dose proportionality of 5 doses (1.38, 2.75, 5.5, 8.25, and 11.0 mg) of Lafenta, a novel matrix-type transdermal fentanyl patch with a rate-controlling membrane; and (2) compare patch bioequivalence (11.0 mg) with a commercially available reference patch (Durotep MT Patch [16.8 mg]). Pharmacokinetics, adhesion performance, residual fentanyl, and safety parameters were assessed. Increases in mean AUC

Indexed as

Administration, CutaneousAdultAnalgesics, OpioidArea Under CurveBiological AvailabilityCross-Over StudiesDose-Response Relationship, DrugDrug CompoundingDrug Delivery SystemsDrug ToleranceFentanylHealthy VolunteersHumansJapanNaltrexoneNarcotic AntagonistsAnalgesics, OpioidFentanylNaltrexoneNarcotic Antagonistsbioequivalencedose proportionalityfentanylJapanesepharmacokineticphase 1transdermal patch

Identifiers

PMID32748570
PMCPMC7984375
OpenAlexW3047320139

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.