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NCT03424135 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions
A Phase 1 study of Clinical Pharmacology, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03424135: Completed Phase 1 study of Clinical Pharmacology, sponsored by Bayer.
NCT03424135 is a Phase 1 study of Clinical Pharmacology that has completed, run by Bayer. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03424135, a Phase 1 study of Clinical Pharmacology, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the relative bioavailability of naproxen sodium/diphenhydramine hydrochloride (DHP HCL) 220/25 mg soft capsules (Test) versus naproxen sodium/DPH HCl 220/25 mg tablets (Reference) after a single oral administration (2 x naproxen sodium 220 mg and DPH HCl 25 mg combination product) under fed conditions in healthy adult subjects. To assess the safety and tolerability of the investigational products in terms of adverse events (AEs) and clinical parameters (systolic/diastolic blood pressure, pulse rate, physical examination, clinical and laboratory testing).
Primary Outcome
Area under the concentration vs. time curve from zero to infinity after single (first) dose
Conditions Studied
Interventions
- DRUG Naproxen sodium and diphenhydramine hydrochloride soft capsules
- DRUG Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)
Study Locations (1)
Texas
- ICON Development Solutions, LLC - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-03-02 |
| Est. Completion | 2018-04-04 |
| Phase | Phase 1 |
What the finished NCT03424135 record still lists
NCT03424135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Clinical Pharmacology appearing as the primary indexed condition, and to 2 interventions - of which Naproxen sodium and diphenhydramine hydrochloride soft capsules is the first listed.
NCT03424135 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03424135 about?
NCT03424135 is a clinical study titled "A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions". To evaluate the relative bioavailability of naproxen sodium/diphenhydramine hydrochloride (DHP HCL) 220/25 mg soft capsules (Test) versus naproxen sodium/DPH HCl 220/25 mg tablets (Reference) after a single oral administration (2 x naproxen sodium 220 mg and DPH HCl 25 mg combination product) under ...
What is the current status of trial NCT03424135?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2018-03-02. Estimated completion is 2018-04-04.
What conditions does trial NCT03424135 study?
This clinical trial studies the following conditions: Clinical Pharmacology.
What interventions are being tested in trial NCT03424135?
The interventions under investigation include: Naproxen sodium and diphenhydramine hydrochloride soft capsules (DRUG), Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111) (DRUG).
Who is sponsoring clinical trial NCT03424135?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03424135 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03424135's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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