NCT03424135View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 2, 2018

Primary Completion Date

April 4, 2018

Study Completion Date

April 4, 2018

Conditions
Clinical Pharmacology
Interventions
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)

Trial Locations (1)

78219

ICON Development Solutions, LLC, San Antonio

Sponsors

Lead Sponsor

Bayer
All Listed Sponsors
lead

Bayer

INDUSTRY