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NCT05844995 · ClinicalTrials.gov registry record · Phase 1
A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain
A Phase 1 study, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT05844995 is a Phase 1 study that has completed, run by Johnson & Johnson Consumer Inc. (J&JCI). The registered enrollment target is 24 participants.
The verdict
NCT05844995, a Phase 1 study, has completed, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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.
Interventions
- DRUG Acetaminophen/Naproxen Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-09-13 |
| Est. Completion | 2024-02-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05844995
The ClinicalTrials.gov registry entry for NCT05844995 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Consumer Inc. (J&JCI), which has 40 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Acetaminophen/Naproxen Sodium is the first listed.
NCT05844995 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05844995 about?
NCT05844995 is a clinical study titled "A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain". 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 subjec...
What is the current status of trial NCT05844995?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-09-13. Estimated completion is 2024-02-14.
What interventions are being tested in trial NCT05844995?
The interventions under investigation include: Acetaminophen/Naproxen Sodium (DRUG).
Who is sponsoring clinical trial NCT05844995?
This trial is sponsored by Johnson & Johnson Consumer Inc. (J&JCI), which has 40 total clinical trials registered on ClinicalTrials.gov.
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