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NCT03396250 · 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
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03396250 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 36 participants.
The verdict
NCT03396250, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects. To assess the safety and tolerability of the investigational products in terms of advent events (AEs) and clinical parameters.
Interventions
- DRUG Naproxen sodium and diphenhydramine hydrochloride soft capsules
- DRUG Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2018-03-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03396250
The ClinicalTrials.gov registry entry for NCT03396250 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 0 conditions, and to 2 interventions - of which Naproxen sodium and diphenhydramine hydrochloride soft capsules is the first listed.
NCT03396250 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03396250 about?
NCT03396250 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". To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adu...
What is the current status of trial NCT03396250?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-02-12. Estimated completion is 2018-03-29.
What interventions are being tested in trial NCT03396250?
The interventions under investigation include: Naproxen sodium and diphenhydramine hydrochloride soft capsules (DRUG), Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111) (DRUG).
Who is sponsoring clinical trial NCT03396250?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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