CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Acetaminophen/Naproxen Sodiumdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05844995
NCT05844995Phase 1Completed
CompareCT.gov

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

Johnson & Johnson Consumer Inc. (J&JCI)·interventional·Posted May 6, 2023·Updated Mar 15, 2024

In Brief

A Phase 1 clinical trial evaluating Acetaminophen/Naproxen Sodium for Orthodontic Pain. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOrthodontic Pain
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedMay 6, 2023
Enrollment StartSep 13, 2023
Primary CompletionFeb 12, 2024
Study CompletionFeb 14, 2024
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.2 years ago

Interventions

Acetaminophen/Naproxen Sodiumdrug

Fixed dose combination of acetaminophen/naproxen sodium tablet will be administered orally.