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.
Administration, Cutaneous
Adult
Analgesics, Opioid
/ administration & dosage
Area Under Curve
Biological Availability
Cross-Over Studies
Dose-Response Relationship, Drug
Drug Compounding
/ methods
Drug Delivery Systems
Drug Tolerance
/ ethnology
Fentanyl
/ administration & dosage
Healthy Volunteers
/ statistics & numerical data
Humans
Japan
/ epidemiology
Naltrexone
/ administration & dosage
Narcotic Antagonists
/ administration & dosage
Reproducibility of Results
Safety
Therapeutic Equivalency
Transdermal Patch
/ adverse effects
Japanese
bioequivalence
dose proportionality
fentanyl
pharmacokinetic
phase 1
transdermal patch
Journal
Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
17
02
2020
accepted:
07
06
2020
pubmed:
5
8
2020
medline:
22
12
2021
entrez:
5
8
2020
Statut:
ppublish
Résumé
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
Identifiants
pubmed: 32748570
doi: 10.1002/cpdd.846
pmc: PMC7984375
doi:
Substances chimiques
Analgesics, Opioid
0
Narcotic Antagonists
0
Naltrexone
5S6W795CQM
Fentanyl
UF599785JZ
Types de publication
Clinical Trial, Phase I
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
260-271Informations de copyright
© 2020 The Authors. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.
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