clinical trial · NCT05844995
A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain
Johnson & Johnson Consumer Inc. (J&JCI)·phase1·completed·n = 24
Orthodontic PainAcetaminophen/Naproxen Sodium
brief summary
The purpose of this study is to investigate the population pharmacokinetics of acetaminophen and naproxen from a novel acetaminophen /naproxen sodium fixed combination tablet in adolescents 12 to less than (\<) 17 years of age with post-procedure orthodontic pain and to describe the effect of subject-specific covariates, including age and body weight, on inter-subject variability in acetaminophen and naproxen pharmacokinetics in adolescents 12 to \<17 years of age with post-procedure orthodontic pain.
started
Sep 13, 2023
primary completion
Feb 12, 2024
completion
Feb 14, 2024
last updated
Mar 15, 2024
official title
An Open-label, Single-dose, Pharmacokinetic Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Orthodontic Pain
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol