A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 12, 2018

Primary Completion Date

March 26, 2018

Study Completion Date

March 29, 2018

Conditions
Pain
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, PMBAY98-7111)

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

All Listed Sponsors
lead

Bayer

INDUSTRY