Bioequivalence of a New Pediatric Paracetamol Oral Suspension Compared With a Marketed Formulation in Healthy Adults: A Randomized, Open-Label Study.
acetaminophen
child
clinical trials
pharmacology
therapeutic equivalence
Journal
Current therapeutic research, clinical and experimental
ISSN: 0011-393X
Titre abrégé: Curr Ther Res Clin Exp
Pays: United States
ID NLM: 0372621
Informations de publication
Date de publication:
2024
2024
Historique:
received:
09
06
2023
accepted:
25
01
2024
medline:
28
2
2024
pubmed:
28
2
2024
entrez:
28
2
2024
Statut:
epublish
Résumé
A new oral paracetamol formulation with the same paracetamol quantity (24 mg/mL) as a marketed formulation but with finer active ingredient particle size and lower amounts of maltitol (5.85 g/dose in the test formulation vs 7.25 g/dose in the reference formulation) and sorbitol (2.4 g/dose vs 2.83 g/dose) was developed. Establish the bioequivalence of the new pediatric formulation (test treatment) compared with the marketed formulation (reference treatment). This Phase I, open-label trial assigned healthy adult volunteers to a single 42-mL (1 g para-cetamol) dose of test or reference treatment. Participants received both treatments in a randomized order separated by a 72-hour washout period. The primary endpoints were AUC Thirty-five participants were randomized and treated. The study population was 42.9% women (57.1% men) with a median age of 30 years; most participants were non-Hispanic White. Mean C The new paracetamol formulation is bioequivalent to the marketed formulation.
Sections du résumé
Background
UNASSIGNED
A new oral paracetamol formulation with the same paracetamol quantity (24 mg/mL) as a marketed formulation but with finer active ingredient particle size and lower amounts of maltitol (5.85 g/dose in the test formulation vs 7.25 g/dose in the reference formulation) and sorbitol (2.4 g/dose vs 2.83 g/dose) was developed.
Objective
UNASSIGNED
Establish the bioequivalence of the new pediatric formulation (test treatment) compared with the marketed formulation (reference treatment).
Methods
UNASSIGNED
This Phase I, open-label trial assigned healthy adult volunteers to a single 42-mL (1 g para-cetamol) dose of test or reference treatment. Participants received both treatments in a randomized order separated by a 72-hour washout period. The primary endpoints were AUC
Results
UNASSIGNED
Thirty-five participants were randomized and treated. The study population was 42.9% women (57.1% men) with a median age of 30 years; most participants were non-Hispanic White. Mean C
Conclusions
UNASSIGNED
The new paracetamol formulation is bioequivalent to the marketed formulation.
Identifiants
pubmed: 38414712
doi: 10.1016/j.curtheres.2024.100734
pii: S0011-393X(24)00004-3
pmc: PMC10897852
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100734Informations de copyright
© 2024 The Author(s).
Déclaration de conflit d'intérêts
This study was sponsored by Haleon. The funder contributed to and collaborated with the investigators on the study design, data collection and analysis, decision to publish, and preparation of the manuscript. M. Armogida, M. Cavinato, and P. Kachroo are employees and shareholders of Haleon CH SARL, Nyon, Switzerland. M. Araga and K. Siddiqui are employees of Haleon, Warren, NJ. The authors have indicated that they have no other conflicts of interest regarding the content of this article.