NCT05844995

A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 12 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Orthodontic Pain

Interventions

Type	Name	Description
DRUG	Acetaminophen/Naproxen Sodium	Fixed dose combination of acetaminophen/naproxen sodium tablet will be administered orally.

Timeline

• Start date: 2023-09-13
• Primary completion: 2024-02-12
• Completion: 2024-02-14
• First posted: 2023-05-06
• Last updated: 2024-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study