| Autor: |
Jiri Grim, MD, PhD, Marianna Armogida, MD, Preeti Kachroo, BAMS, MD(AM), Kamran Siddiqui, MBBS, MBA, Mauro Cavinato, PhD, Mako Araga, MS |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
Current Therapeutic Research, Vol 100, Iss , Pp 100734- (2024) |
| Druh dokumentu: |
article |
| ISSN: |
0011-393X |
| DOI: |
10.1016/j.curtheres.2024.100734 |
| Popis: |
ABSTRACT: Background: 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: Establish the bioequivalence of the new pediatric formulation (test treatment) compared with the marketed formulation (reference treatment). Methods: 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 AUC0–tlast (AUC vs time curve from time 0 to last measurable sampling timepoint), Cmax, and tmax. Safety assessments included adverse event, clinical laboratory, and physical examination data. Results: 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 Cmax values were comparable between test and reference products, with a median tmax of 1.00 hour for both. The test/reference ratios (%) (90% CI) for AUC0–tlast and Cmax were 98.69% (96.46, 100.97) and 100.73% (95.63, 106.10), respectively. There were no adverse events or deaths. Conclusions: The new paracetamol formulation is bioequivalent to the marketed formulation. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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