Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study of Clinical Pharmacology that has completed, run by Bayer. The registered enrollment target is 60 participants. The trial reports 1 study location across 1 state.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03424135
The ClinicalTrials.gov registry entry for NCT03424135 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.