NCT03424135

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

An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

• Clinical Pharmacology

Interventions

Type	Name	Description
DRUG	Naproxen sodium and diphenhydramine hydrochloride soft capsules	Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)
DRUG	Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)	Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)

Timeline

• Start date: 2018-03-02
• Primary completion: 2018-04-04
• Completion: 2018-04-04
• First posted: 2018-02-06
• Last updated: 2019-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study